Download View/Open - UoN Repository

UNIVERSITY OF NAIROBI
PATTERNS AND CLINICAL OUTCOMES OF SURGICALLY TREATED
CERVICAL SPINE DEGENERATIVE DISC DISEASE AT THE MOI
TEACHING AND REFERRAL HOSPITAL, ELDORET.
DR. BOEN BARNABAS KIPNGETICH, MBChB (UoN)
REG. NO. H58/65061/2010
THESIS SUBMITTED IN PARTIAL FULFILLMENT FOR THE AWARD OF
MASTERS OF MEDICINE IN NEUROSURGERY
UNIVERSITY OF NAIROBI
2014
1
UNIVERSITY OF NAIROBI
DECLARATION
I declare that this thesis is my original work and has not been presented for the award of a
degree in any other university.
Dr. Boen B. Kipngetich MBChB (UoN)
H58/65061/2010
Signed: ______________________________ Date: _____________________
i
UNIVERSITY OF NAIROBI
SUPERVISORS
Dr. Florentius K. Koech,
MBChB, MMed Surgery (U.O.N), Neurosurgery, Melbourne (Australia), Occ. Health
(Japan),
Fellow in Neurosurgery and Complex Spine,
Consultant Neurosurgeon and Senior lecturer,
Moi University School of Medicine.
Sign………………………………Date………………………………
Dr. Kiboi Julius Githinji,
MBChB (U.O.N), MMed Surgery (U.O.N), Supernumerary Neurosurgery Training
Pretoria Academic Hospital, University of Pretoria, South Africa,
Consultant Neurosurgeon and Senior Lecturer,
Department of Surgery, Division of Neurosurgery,
University of Nairobi.
Sign……………………………….Date……………………………..
Prof. Mwang’ombe Nimrod J. M.
MBChB, MMed (Surg), PHD (Lond), FCS (ECSA).
Head, Division of Neurosurgery,
Department of Surgery,
University of Nairobi.
Sign………………………………Date………………………………
ii
UNIVERSITY OF NAIROBI
TABLE OF CONTENTS
DECLARATION ................................................................................................................. i
SUPERVISORS .................................................................................................................. ii
TABLE OF CONTENTS ................................................................................................... iii
LIST OF ACRONYMS ..................................................................................................... vi
DEFINITION OF TERMS ............................................................................................... vii
ABSTRACT ..................................................................................................................... viii
CHAPTER ONE ................................................................................................................. 1
INTRODUCTION AND LITERATURE REVIEW .......................................................... 1
1.1 Introduction ................................................................................................................... 1
1.2 Literature review ........................................................................................................... 3
1.2.1 Overview .................................................................................................................... 3
1.2.2 Cervical Degenerative Disease (CDD) ...................................................................... 5
1.2.2.1 Pathophysiology...................................................................................................... 5
1.2.2.2 Symptoms and signs of Cervical Spine Disc Disease ............................................. 9
1.2.2.3 Diagnosis of CDDD……………………………………………………………….10
1.2.3.0 Treatment of cervical spine degenerative disc disease…………… …………… 11
1.2.3.1 Non surgical treatment……………………………….……………… ………… 11
1.2.3.2 Surgical treatment…………………………………………………………. ……11
1.2.4.0 Clinical outcomes.................................................................................................. 18
1.2.4.1 Functional outcomes……………………………………………………………..18
1.2.4.2 Complications of surgery………………………………………………………...20
iii
UNIVERSITY OF NAIROBI
CHAPTER TWO .............................................................................................................. 22
2.1 Statement of the Problem ............................................................................................ 22
2.2 Justification of the Study ............................................................................................ 24
2.3 Study Rationale ........................................................................................................... 24
2.4 Aim and objectives of the study.................................................................................. 25
2.4.1 Aim .......................................................................................................................... 25
2.4.2 Objectives ................................................................................................................ 25
CHAPTER THREE .......................................................................................................... 26
MATERIALS AND METHODS ...................................................................................... 26
3.1 Study Area .................................................................................................................. 26
3.2 Study Design ............................................................................................................... 26
3.3 Study Population ......................................................................................................... 26
3.4 Sample Design and Procedure .................................................................................... 26
3.4.1 Study period ............................................................................................................. 26
3.4.2 Sample Size Determination...................................................................................... 27
3.4.3 Inclusion Criteria ..................................................................................................... 28
3.4.4 Exclusion Criteria .................................................................................................... 28
3.5 Data Collection Instruments and Techniques ............................................................. 29
3.5.1 Data Collection Tools and methods ......................................................................... 29
3.5.2 Actual Data Collection Phase .................................................................................. 30
3.6 Data Analysis, Presentation and dissemination .......................................................... 30
3.7 Ethical Considerations ................................................................................................ 31
3.7.1 Confidentiality ......................................................................................................... 31
iv
UNIVERSITY OF NAIROBI
3.7.2 Ethical approval and termination of the study ......................................................... 31
3.8 Limitations and delimitations ..................................................................................... 32
3.8.1 Limitations ............................................................................................................... 32
3.8.2 Delimitations ............................................................................................................ 32
CHAPTER FOUR: FINDINGS……………………………………………………..…...33
4.1 FLOW CHART…………………………………………………………….………...33
5.0/ 5.1 DISCUSSION ...................................................................................................... 49
5.2 Conclusions ................................................................................................................. 63
5.3 Limitations .................................................................................................................. 63
5.4 Recommendations ....................................................................................................... 65
REFERENCES ................................................................................................................. 66
APPENDICES .................................................................................................................. 73
APPENDIX I: CONSENT FORM FROM THE PATIENT ............................................. 73
KIAMBATISHO I: FOMU YA IDHINI KUTOKA KWA MGONJWA ........................ 74
APPENDIX II ................................................................................................................... 75
MODIFIED RANKIN SCALE (MRS) ............................................................................. 77
VISUAL ANALOG SCORE (VAS)…………………………………………………….78
BUDGET ESTIMATES ................................................................................................... 79
STUDY TIME FRAME .................................................................................................... 79
v
UNIVERSITY OF NAIROBI
LIST OF ACRONYMS
CDD:
Cervical Degenerative Disease
DDD:
Degenerative Disc Disease
CSF:
Cerebrospinal Fluid
CSM:
Cervical Spondylotic Myelopathy
VAS:
Visual Analog Score for pain. Most common pain scale for
Subjective quantification.
MTRH
Moi Teaching and Referral Hospital, Eldoret, Kenya.
MRS:
Modified Rankin Scale for measuring the degree of disability
Or dependence in the daily activities of people with neurologic disability.
PGIC:
Patients’ Global Impression of Change
SPSS:
Statistical Package for Social Scientist
AIDA:
Artificial Intervertebral Disc Arthroplasty
MRI:
Magnetic Resonance Imaging
IVD:
Intervertebral Disc
UoN:
University of Nairobi
vi
UNIVERSITY OF NAIROBI
DEFINITION OF TERMS
Arthropathy:
Pathological process affecting a joint.
Arthroplasty:
A surgical procedure whose aim is to restore the function of a
joint. Usually by resurfacing the bones, or by replacing it with an
artificial joint.
Cervical spondylosis: Is a medical term used to refer to age-related ‘wear and tear’ that
can affect bones and tissues in the neck.
Cervical:
Referring to the neck region. There are seven cervical vertebrae.
Foramen:
(plural foramina) Channels in bone, through which blood vessels
or nerves traverse.
Herniation:
Bulging through a weakness in supporting structures.
Myelopathy:
Any neurologic deficit related to the spinal cord. It is usually due
to compression of the spinal cord by dics extrusion or osteophyte
Osteophyte:
A spur-like outgrowth of bone.
Paraesthesiae:
Abnormal sensations – burning, prickling, “pins and needles”.
Psychosocial:
Involving both psychological aspects and social background; e.g.
the patient’s age, education, occupation, family and related factors.
Radiculopathy:
Dysfunction of a nerve root, usually due to compression
Spondylosis:
Degenerative conditions affecting the spine including disc
degeneration, herniation facet arthrosis & osteophytic
spur formation.
vii
UNIVERSITY OF NAIROBI
Patterns And Clinical Outcomes Of Surgically Treated Cervical Spine Degenerative
Disc Disease At The Moi Teaching And Referral Hospital, Eldoret
ABSTRACT
Background: Degenerative disc disease is a condition characterized by wear and tear of the
intervertebral disc. It occurs in a variety of clinicopathologic conditions including cervical
spondylosis. Locally, there is no data describing the patterns and clinical outcomes of surgically
treated cervical spine degenerative disc disease.
Objective: To determine the patterns and clinical outcomes of surgically treated cervical spine
degenerative disc disease.
Methods: This was a prospective cross sectional study involving all patients who underwent
cervical spine surgery secondary to degenerative disc disease at the Moi Teaching and Referral
Hospital, Eldoret during the period October 2014 and July 2015. Data variables collected were
biodata, clinical parameters, surgical procedures done, complications and the clinical outcome. It
was entered into a structured questionnaire. Data was analyzed using SPSS version 19.0 and
presented in form of graphs and tables. Ethical approval was obtained from MTRH before the
study commenced.
Results: There were a total of 44 patients sampled. The mean age was 56±13 years. Thirty three
patients (75%) were male. Twenty three patients (52%) were doing manual labour while nine
(21%) were doing clerical work. Twenty five (57%) had experienced radiculopathy for more than
6 months. Myelopathy was present in eleven (25%) while four (9%) had upper limb weakness for
more than six months. Seventeen patients (39%) had radiculopathy while fifteen (36%) had neck
pain for less than six months. History of previous neck trauma was present in twenty eight
patients (64%), Family history of DDD was present in nine (21%), alcohol intake was present in
eighteen (41%) while sixteen (36%) reported smoking cigarette. Thirteen patients (30%) had
C5/C6 disc level affected, three patients (7%) had C3/C4, five (11%) had C4/C5. The main
indications for surgery were severe pain/ radiculopathy present in thirty nine (89%) and failed
conservative management in sixteen (36%). The median preoperative visual analogue scale for
pain was 6 (IQR: 5 to 7) while the twelve week post-operative pain score was 2 (IQR: 1 to 3) with
significant median difference being -4 (IQR: -5, to -3). There was significant differences in the
VAS score outcome measure across the age groups, (p=0.018) and gender, (p=0.035). Male
patients and the elderly had smaller change compared to female and younger patients
respectively. Post surgery MRS score significantly reduced (p<0.0001) with median preoperative
MRS score being 3(IQR: 2 to 4) while the median twelve week post operative MRS score was 1
(IQR: 0 to 1). Post-surgery complications were reported in nine patients (20%). Three patients,
(7%) had dysphagia while another four (9%) had neck pain. Three (7%) had post-operative
haematoma while two patients (5%) died.
Conclusion: cervical DDD is common in male. Trauma was the most common predisposing
factor for CDDD. Pain/ Radiculopathy was the most presenting symptom and indication for
surgery. ACDF with cage and plate was the most common operative procedure and associated
with improved outcomes.
viii
UNIVERSITY OF NAIROBI
CHAPTER ONE
INTRODUCTION AND LITERATURE REVIEW
1.1 Introduction
Globally, degenerative cervical spine disorders are estimated to affect up to 75% of the
human population in their entire lifetime1. Therefore, many societies consider cervical
degenerative disease (CDD) a major public health issue. Though pain along the cervical
spine may be related to muscle sprains and facet related pain it could also be related to
degeneration of the cervical discs 1. In Western countries, the lifetime incidence of neckrelated pain is reported to be as high as 67%. It is noted that among the following groups
of people in whom cervical related complaints are very common; the educated populace,
patients presenting with a history of headaches and low back pain and those with a
previous history of whiplash or traumatic injury2. Currently, degenerative disorders of the
cervical spine remain a common diagnosis in the general population1.
The aetiology of symptomatic degenerative disease of the spine is complex and not fully
understood 3. Nevertheless, many of the cervical spine disorders are self limiting and can
be treated non-operatively1. Therefore, it is important that the immediate goals in
treatment of CDDD should include controlling a patient’s pain while limiting the impact
of the disease on their daily life. In the long term though, restoration of function should
be the major goal. This is despite the fact that in some patient’s restoration of functions
may be a slow and arduous process. Important considerations in the assessment of
cervical spine patients include; the location, as well as the duration and quality of pain1.
1
UNIVERSITY OF NAIROBI
In the last 50 years, advancements in the treatment of cervical spine degenerative
disorders have been many. There have been concerted efforts to halt or reverse the
degenerative process by means of various biological therapies, although these are still in
experimental stages1. Currently, the treatment of degenerative spinal diseases remains
focused on dealing with symptoms, using both conservative and surgical methods 4.
Though surgery is considered an effective treatment for many cervical disorders, at times
it leads to significant problems including adjacent level disease 1.
According to Fineberg et al., 5 the overall rate of complications and mortality as a result
of spine surgery on the cervical spine is higher in teaching hospitals than in non-teaching
hospitals. At the teaching hospitals, cervical spine patients demonstrated longer
hospitalization with increased costs of surgery, and higher mortality than those treated in
non-teaching hospitals. The study carried out in the US shows that patients who
underwent a cervical spine surgery at teaching hospitals stayed 0.3 days longer in the
hospital, incurred Usd500 more in costs with a higher complication rate (2.47% vs.
1.74%) when compared to those at non-teaching hospitals. The mortality rate was also
higher in the teaching hospitals 5.
To minimize the “footprints” arising from surgical interventions on the cervical spine, it
is crucial not only to treat the present disorder but also avoid sowing the seeds of future
problems. A milieu should also be created that can easily address these problems should
they arise.
2
UNIVERSITY OF NAIROBI
1.2 Literature review
1.2.1 Overview
The spinal canal plays a great role in the human body and houses the spinal cord along
with the cerebrospinal fluid (CSF) and meninges 6. The occurrence of degenerative
changes on the cervical spine can lead to the spinal cord being compressed 6. Codivilla
(1907) first described compression of a C4 nerve root by transverse process of C4/C5
vertebra. Subsequently however, there is paucity of data that describes further history of
the condition before the 19th century 7. Degenerative disc disease is one of the most
frequent spinal disorders 4. In the developed countries, the rate of growth of the elderly
population supersedes that of the entire population 8. As a result, there is an increase in
the prevalence of degenerative spinal disease
9
.
According to the 2014 Kenya
demographic and health survey (KDHS-2014), the Kenyan population has increased from
10.9 million in 1969 to 45 million in 2014 with an estimated growth rate of 2.11%. The
younger and working population (25- 54 years) constituted 32.8% and supersedes the
elderly population (> 55 years) that constituted 6.5% of the entire population 10.
Degenerative cervical spine disorders are known to affect up to 2/3rds of the people in their
entire life. It is commonly seen in individuals after the age of 40 years and is believed to
be part of the normal aging process of the vertebral column 1.While often episodic and
benign naturally, cervical spine disc disorders can be debilitating hence resulting in
severe pain and possibly neurologic sequelae 1. Cervical DDD results from spinal
spondylosis and causes deterioration of the intervertebral discs of the cervical spine.
3
UNIVERSITY OF NAIROBI
Desiccation of the cervical discs leads to disintegration of the index level segment and
subsequently leading to abnormal motion of the spinal column 1.
Degenerative disc disease of the cervical spine is a common medical condition in the
population with underlying aging, genetic, mechanical and environmental factors
11
. It is
characterized with structural collapse, osteophyte formation and loss of the loading
function of the intervertebral disc. As a consequence, a compression of neural structures
is observed with axial neck pain, cervical radiculopathy and myelopathy
12
. Cigarette
smoking and neck trauma are amongst the commonest acquired environmental
predisposing factors to CDDD
12
. The prevalence of degenerative disc disease increases
with aging. It is estimated that 80% of people older than 55 years have evidence of DDD
on X ray13. In one natural history based study, up to 45% of patients have a single
episode of cervical radiculopathy and up to 33% have intermittent attacks 14.
In a study that was conducted using magnetic resonance imaging (MRI) involving 497
healthy individuals without symptoms related to the cervical spine, it was found that the
prevalence of disc degeneration increased with age; 5-10% by the age of 20-30 years, >50%
by age 45 years, and up to >90% by 60 years of age. Decrease in signal intensity of
intervertebral disc was observed on the MR images in 17% of males and 12% of females
aged 20–29 years and 86% of males and 89% of females aged 60–69 years 15.
In Africa, there are few studies on cervical spondylosis and its management 16.
Considering age as one of the most important predictors of cervical spondylosis, the
prevalence of cervical spondylosis does not seem to differ from that in other parts of the
4
UNIVERSITY OF NAIROBI
world. Patients however are often diagnosed very late in the course of the illness when
irreversible changes and progressive neurological deficits have already occurred. This
may be due to inadequate diagnostic facilities and suspicion on the part of the care takers
16
.
1.2.2 Cervical Degenerative Disease (CDD)
1.2.2.1 Pathophysiology
The cervical spine, with 37 separate joints (including six intervertebral discs), constitutes
the most complicated articular system in the body
17
. The normal cervical spine moves
approximately 600 times every hour, whether the individual is awake or asleep. Clinically
it is of importance with regard to degenerative conditions
17
. Whereas thoracic and
lumbar spine degenerative disc disease manifest as complex deformities with
decompensation involving coronal and sagittal planes, cervical spine degenerative
diseases on the other hand often presents with isolated sagittal plane deformity 9.
Degenerative disease in the cervical spine is a common source of axial neck pain and
neurologic disturbances 9. In addition to pain, upper extremity radiculopathy and
myelopathy, advanced cervical degenerative disease can result in altered biomechanics,
most commonly manifested as a kyphotic deformity 9.
Cervical spondylosis is used to describe the degenerative process that encompasses a
sequence of changes in the intervertebral disc, vertebral bodies, joints, and/or ligaments
of the cervical spine 18. Although the exact pathophysiology underlying cervical
spondylotic myelopathy remains uncertain, it is largely accepted to be a disorder that
involves compressive forces on the spine, likely due to multiple factors 18.
5
UNIVERSITY OF NAIROBI
Dysfunction of the intervertebral joints, root canal stenosis and the cervical canal stenosis
can arise as a result of the pathophysiological processes involved in cervical spondylosis
19
. Degeneration of these joints can also be induced by disc degeneration accompanied by
height reduction which in turn increases the axial load on the facet joints 20. KirkaldyWillis 21 described three pathophysiologic stages involved in CDDD;
1. Initial dysfunction stage: characterised by circumferential and radial tears within the
annulus fibrosus and synovitis involving the uncovertebral and facet joints.
2. Instability stage: characterised by internal disc disruption, resorption, and
degeneration of the facet joint accompanied by capsular laxity, subluxation and joint
erosion, and finally
3. Stability stage: where hypertrophic bone around the discs and facet joints lead to
segmental stiffening or ankylosis 21.
C5/C6 disc is most vulnerable to degenerative disease due to the fact that the greatest
decrease in sagittal diameter over time is at the C5/C6 and the C6/C7 levels. This
decrease at these levels correlates significantly with disc space narrowing
22
.
Furthermore, C5/C6 and C6/C7 segments of the cervical spine control most flexion and
extension movements in the neck with most compressive symptoms generated in the C5
to C7 region hence its vulnerability in trauma as a precursor to CDDD 23. In addition, the
spinal canal is narrowest at this level and the spinal cord, which averages 10 millimeters
in its anterioposterior diameter (range of 8.5 to 11.5 millimeters), occupying three quarter
of the canal in the normal cervical spine at the C6 level 23.
6
UNIVERSITY OF NAIROBI
Williams et al.,
24
identified increased levels of metalloproteinases, prostaglandin E2,
nitrous oxide and interleukin-6 in retrieved disc material, suggesting that these substances
are intimately involved in the degenerative process as well as in axial pain production 24.
These biochemical processes results in mechanical change with loss of disc height and
subsequent disc bulging posteriorly leading to decreased canal and foraminal dimensions,
and reduced area available for the neurological structures 25. With increased utilization of
MRI, cord compression is directly visualised anteriorly by disc pathology. Cord signal
changes and cord deformation confirm myelopathy
25
. In addition to the mechanical
compression on the cord, there is also an alteration of the blood supply causing
destruction of both grey and white matter
25
. Anterior compression compromises
perfusion through the transverse arterioles that arise from the anterior sulcal arteries,
while posterior cord compression reduces perfusion to the intramedullary branches of the
central grey matter 25. Therefore, the pathological course of cervical spondylotic myelopathy is
characterized by early involvement of the corticospinal tracts, and relative preservation of
anterior columns due to the ensuing ischaemia. This may cause ascending and descending
demyelination above and below the level of the compression and mainly affecting the
pyramidal tracts 25.
Fehlings et al., 26 did radiographical study of the spinal canal in cervical spondylosis and
revealed three types of degenerative encroachment in the cervical spinal canal. These
include: obliteration of the neural foramen by osteophytic overgrowth at the
posterolateral margin of the vertebral body; encroachment on the neural canal by an
osteophytic spur which in turn produces an impression on the spinal cord by direct
7
UNIVERSITY OF NAIROBI
compression and the effect of degeneration, hypertrophy; and buckling of the ligamentum
flavum 26.
In Africa, the daily lifestyle is different compared to North America or Europe. Carrying
objects on the head, for example, is a very common practice in some African countries 27.
Jäger et al. in a case control study, evaluated the relationship between load-carrying on
the head and the development of degenerative changes in the cervical spine of 70
Ghanaians. In 31 out of the 35 (89%) carriers, degenerative changes were found in the
cervical spine. These changes were found in only 8 of the 35 (23%) non-carriers, leading
to a conclusion that the axial strain of carrying load on the head exacerbates degenerative
change in the cervical spine, with consecutive narrowing of the medullary canal. Age and
the weight carried seem to be important factors in the development of degenerative
changes in this subpopulation 27.
Taitz studied the difference between cervical spines in cadavers of South African blacks
and whites and found that the cervical vertebrae of whites were significantly more
affected than their black counterparts. In addition, the distribution of Osteophytosis in
blacks was found to be different from whites; osteophytes appeared to affect either the
vertebral body or apophysial joint facets in the cervical vertebrae of the blacks. In the
whites, in sharp contrast, both sites were often affected on the same vertebra, which in
life may result in a pincer-like entrapment of the spinal nerve root and/or vertebral
artery28.
8
UNIVERSITY OF NAIROBI
1.2.2.2 Symptoms and signs of Cervical Spine Disc Disease
Patients with cervical degenerative disc disease (disc herniation and/or spondylotic
changes) often present with complex symptomatology 29. The symptoms mainly include
disc-specific as well as non-disc specific. Symptoms include neck pain, distinct, severe
arm pain/ radiculopathy, numbness and sensory loss, motor loss/ myelopathy and
abnormalities in reflexes. Furthermore, the presenting symptoms are often followed by
both physical and psychologic disability, persistent illness, leading to long periods of
sick-leave, and difficulties in resuming work 29.
Clinical experience has demonstrated that patients with cervical degenerative disc disease
commonly experience dizziness and difficulty balancing, scientifically, there is little
known as regards this phenomenon 30.
Myelopathic signs include hyperreflexia of deep tendon reflexes of the upper and lower
extremities, increase in muscle tone or clonus, and the presence of pathological reflexes
that include plantar reflex (Babinski’s sign) and/or Hoffman’s sign. Hoffman’s sign is
also referred to as the “upper extremity Babinski’s sign”. It is elicited by stimulating the
extensor tendon of the third digit by forcibly flexing its distal phalanx, followed by a
sudden release. This results in a flexion and adduction movement of the thumb and
concurrent flexion of the index finger 30.
There is also atrophy of the small muscles of the hands, described as “myelopathic hand”,
as a result of segmental anterior horn cell necrosis. Severe cases of cervical spinal canal
9
UNIVERSITY OF NAIROBI
stenosis can also cause paraplegia, and significant loss of function involving the
sphincters 30.
In the treatment of individuals experiencing pain and disability following a whiplash
trauma to the neck as well as other painful conditions, important factors for recovery
include; the patient’s self-efficacy and use of coping strategies 30.
Generally, an acute presentation of neck pain in a young individual most likely indicates
a disc extrusion
31
. The mean age for acute cervical disc herniation is 37 years, with an
equal incidence rate for both males and females
31
. In CDDD, the most commonly
affected discs and nerve roots in order of decreasing frequency are as follows 25:
First
Second
Third
Fourth
Fifth
C5/C6 disc
C6/C7 disc
C4/C5 disc
C3/C4 disc
C7/T1 disc
C6 nerve root
C7 nerve root
C5 nerve root
C4 nerve root
C8 nerve root
1.2.2.3 Diagnosis of CDDD
Diagnosing cervical spine degenerative disorders starts with a good history and physical
examination. Diagnosis is based on observation of neurological symptoms, a detailed
physical examination as aforementioned. Diagnostic imaging studies necessary to
confirm the diagnosis include; X-rays, CT scan, MRI or a myelogram. A hyperintense
cord signal on T2WI signifies myelopathy. These imaging studies are followed in some
cases by other diagnostic studies such as laboratory investigations, neurophysiological or
10
UNIVERSITY OF NAIROBI
cerebrospinal fluid examinations to rule out the differential diagnosis that include:
amyotrophic lateral sclerosis, multiple sclerosis, or subacute combined system disease 32.
1.2.3 Treatment of cervical spine disc disease
1.2.3.1 Non-surgical treatment
Usually the first step is conservative/ non operative treatment. Patients with radicular
symptoms but without weakness or myelopathy can be treated conservatively 38.
Conservative treatment may include; analgesics (oral and/ or parenteral), a short course
of steroids, avoidance of provocative activities, cervical spine traction, neck
immobilization, or use of a cervical pillow and physical therapy 38. Surgery is typically
indicated when six months of conservative therapy have been unsuccessful, if there is a
neurologic deficit attributable to the cervical disc disease or when the symptoms have
progressed in a short time period and interfere with the patient's usual activities 38.
1.2.3.2 Surgical treatment of CDDD
According to Knaub, et al.,
35
the surgical options for management of cervical spine
degenerative disease include; ACDF, anterior corpectomy and fusion (ACCF), and the
posterior procedures of laminectomy or laminoplasty. These may however lead to
significant complications including adjacent level disease 33.
Surgeries aimed at decompressing the cervical spinal nerve root and/or cord have been
established worldwide for the management of radiculopathy
29, 35
. Several studies have
reported that surgeries lead to reduction in pain intensity and neurological deficits, and
11
UNIVERSITY OF NAIROBI
that the overall outcome was good in approximately 80% of cases 29. However, the results
were less favourable when broader, more functional measurements were evaluated 36.
Many patients suffering from cervical disc disease require leave from work due to longlasting, complex symptoms, including chronic pain and reduced levels of psychologic
and physical function
29
. Surgery performed on a few segmental levels may be expected
to resolve disc-specific pain and reduce neurological deficits, but not the non-specific
neck pain and the frequent illness 33.
Long lasting disability, pain, sensory disturbances, and/or paresis caused by compression
of a cervical root are accepted indications for surgery
24
. Most surgeons concur that
patients with clinical signs and/or symptoms of cervical disc degeneration (CDD) and
coinciding MRI findings should be examined and considered for surgical treatment if
they have failed to improve after 8 weeks of conservative treatment 24; Williams, et al., 24
recommended surgery for CDDD in patients having;
1) Axial neck pain with Failure of 6-12 months of conservative management, despite
active rehabilitation, increasing axial pain severe enough to interfere with desired
activities of daily living in a patient with no psychosocial contra-indications,
2) Those with Radiculopathy (Persistent or recurrent arm pain unresponsive to a 6-12
week trial of conservative therapy or an increasing neurological deficit.) as well as
3) Progressive Myelopathy 24
Patients with severe myelopathy should be treated with surgical decompression
29
.
Adequate decompression may arrest the progression of CSM, although this is not always
the case. Patients must be informed before surgery that the best they can expect is
12
UNIVERSITY OF NAIROBI
cessation of the disease and symptom progression but that they may also experience
further disease and symptom progression 29.
Operative techniques for the cervical degenerative disease include; Anterior cervical
discectomy and fusion (ACDF); the Cloward operation, the Smith-Robinson procedure,
cervical prosthesis, cervical laminectomy and cervical laminoplasty
29
. ACDF has
become the method of choice for cervical DDD, more so because of the potential for
greater discomfort and longer hospital stay because of cutting of the paraspinous muscles,
and awareness of post laminectomy deformity 29.
Anterior and posterior approach
The anterior right- or left-sided approach to remove the intervertebral disc is a well
proven, preferred and safe route
19
due to the fact that most of the pathology is anterior
therefore; it allows direct visualisation and decompression of the offending structures
such as the disc and uncovertebral osteophytes, It decompresses the anterior spinal
artery, which supplies the anterior 80% of the spinal cord thereby alleviating any
ischaemic component of the neurology and It allows concomitant deformity correction in
the instance of kyphotic deformity or instability, which is common and often contributes
to the myelopathy, to restore the normal sagittal profile and undrape the cord off the
kyphotic segment
19
. The stabilising effect of fusion protects the cord from repetitive
movement and microtrauma, affording the best environment for healing and functional
recovery 36.
The choice of the right- or left-sided approach is made according to the surgeon’s
preference
18
. Some studies have suggested a greater risk of injury of the recurrent
13
UNIVERSITY OF NAIROBI
laryngeal nerve using a right-sided approach compared with a left-sided approach,
although others found no difference between these approaches 19.
After the skin incision, the surgeon must either make a transverse incision of, or split, the
platysma, as recommended by Cloward
19
. The next step is to dissect medial to the
vessels, taking care not to injure the carotid artery and the common jugular vein. Vascular
injury of the great vessels seems to be rare, but postoperative haematoma is reported in
1.3 - 5.6% of cases 19.
Dysphagia is defined as a subjective increase in the time or effort required to move food
from the mouth to the stomach and is a common complaint after ACDF
19
. There is a
broad range of signs and symptoms; painful swallowing, difficulty swallowing, coughing
or chocking with swallowing, or frequent throat clearing are reported frequently. The
exact explanation for this dysphagia is not clear. Prevertebral soft tissue swelling after
ACDF as a cause of dysphagia is debated 19.
Posterior laminoplasty procedure is seldom used. It is mainly aimed at reducing the risk
of posterior instability and to avoid a spine fusion. According to Spine-Health, the main
advantage of this technique is that it increases the size of the canal but leaves the
posterior tether that helps stabilize the spine
39
. The main weakness is that the spinal
canal is inadequately visualized and thus difficult to assess whether the canal has been
well decompressed or not. Posterior cervical laminectomy is associated with some risks
that include dural tear, infection, bleeding, increase pain and instability in the spinal
column hence overall deterioration of the neurological function 39.
14
UNIVERSITY OF NAIROBI
The posterior surgery for cervical myelopathy with degenerative disc disease is mainly
indicated in treatment of myelopathy that arise from two or more segments
31
. It will
reduce fusion related problems associated with anterior surgery and has certain specific
advantages. Posterior based operations such as laminectomy, laminectomy with fusion
and/or laminoplasty are technically easier to operate in patients with multilevel disease
with severe stenosis, disc herniation, ventral osteophytes or ossification of the posterior
longitudinal ligaments 39.
a) Cervical Spine Fusion Surgery for Degenerative Disc Disease
The most commonly used decompressive surgical procedure in the cervical spine is
Anterior cervical discectomy with/ and fusion (ACDF). According to Smith, et al., 40 the
treatment of disc herniations by anterior cervical discectomy was first popularised by
Robinson and Smith in 1958. ACDF is preferred for most cases as the pathology is
predominantly anterior to the cord and can be removed without having to manipulate the
cord with all the associated risk 25. The aim of the procedure is to remove pressure from
the spinal nerves and to realign and stabilize the spinal segment. The affected disc is
removed anteriorly; discs that are herniated either laterally or midline can be removed 20.
Bony material (either autograft or allograft) is placed into the intervertebral space in
order to stimulate healing and fusion
40
. Insertion of bone graft facilitates fusion, but
more importantly, distracts the bodies and indirectly decompresses the neural foraminae
25
. After removing the disc in its entirety, the endplates are curetted until bleeding bone is
exposed and either a tricortical graft or anterior plates and interbody cages inserted in
15
UNIVERSITY OF NAIROBI
order to stabilize the fusion site and to minimize the need for a post-operative brace
25
.
ACDF is used for the treatment of single or multiple level degenerative disc disease 40.
An important and limiting complication of cervical spine fusion surgery is the
development of DDD in adjacent discs
41
. Artificial intervertebral disc arthroplasty has
been proposed as an alternative that might decrease the incidence of this complication.
Titanium
interbody cage
cervical plate
b) Artificial Intervertebral Disc Arthroplasty
As an alternative to ACDF, artificial intervertebral disc arthroplasty (AIDA) has been
proposed as a surgical treatment for patients with symptomatic cervical DDD. With
AIDA, instead of placing bone in the intervertebral space, an artificial disc is placed. In
contrast to ACDF, an anterior plate is not needed to stabilize the adjacent vertebra and an
external brace is not needed either 42, 43.
16
UNIVERSITY OF NAIROBI
AIDA
pyramesh cage
c) Artificial Cervical Discs
Three cervical artificial discs are usually used. These include the ProDisc-C cervical disc,
the Prestige ST Cervical Disc and the Bryan cervical disc, Medtronic 44. All of the discs
are indicated for use in skeletally mature patients for single level disc disease in levels C3
to C7 44. Candidates for surgery are those who have failed conservative therapy and have
evidence of symptomatic nerve root and or spinal cord compression as documented by
patient symptoms and radiographically 44.
Artificial cervical disc arthroplasty has been proposed as an alternative to ACDF for the
treatment of single level symptomatic cervical DDD. It has the theoretic advantage of a
reduced risk of adjacent segment degeneration. Thus, the question is how the outcomes of
AIDA compare with those of ACDF in patients with symptomatic cervical spine DDD 45.
BRYAN® Disc
PRESTIGE® LP
17
UNIVERSITY OF NAIROBI
1.2.4 Clinical Outcomes
1.2.4.1 Functional outcomes
There are few prospective randomised studies on patients with cervical disc disease that
received
decompressive
surgery
with
long-term
follow-ups
and
functional
measurements46. The available studies have consequently given mixed/ different outcome
results. Peolsson et al.,
46
reported that neck-specific function was not improved in an
average six-year follow-up. Those patients also reported poor health-related quality of
life (EQ-5D 0.61) after surgery, worse than that reported by patients with low-back pain
44
. Moreover, over one third of patients displayed physical deficits, including decreased
range of neck motion, reduced neck and hand muscle strength, and reduced neck muscle
endurance
47, 48
. About two-thirds of patients reported high intensity neck pain, neck-
specific disability, psychological distress, and poor general health. Also, after cervical
spinal surgery, health status tended to be worse in women than in men
47
. At a 3-year
follow-up after surgery, 83% of patients reported neck disorders, and 63% of those
reported daily pain. At one year after surgery, 56% of patients were on full-time sickleave, and 12% were on part-time sick-leave. In another prospective randomised study, at
follow-ups conducted 10 - 13 years after surgery, more than one third remained on sickleave related to the neck
37
. On the other hand, Klein, et al., 49 performed a prospective
assessment using the health status questionnaire of the outcomes for 28 patients with
cervical radiculopathy treated with one- or two-level ACDF. They found that ACDF is a
highly reliable surgical procedure for radiculopathy in well-selected patients, with
18
UNIVERSITY OF NAIROBI
statistically significant improvements in postoperative scores for both pain and function
38, 49
.
In Gabon, Loembe et al. reported the surgical outcome of 18 patients in a surgical
treatment study 50. The patients presented with various progressive spinal cord
pathologies (tetraparesis- 13, paraparesis- 4, and tetraplegia-1) and with varying
spasticity. Anterior surgical approach was used in all 18 cases with an average follow-up
duration of 6.9 years. All patients obtained fusion, and stability was reportedly achieved
after an average of 3-5 months. Neurologic recovery however was complete in 10 cases,
partial in 7 cases and unchanged in one case 50.
Yonenobou et al
51
, looking at cervical myelopathy, found anterior approaches to have
good to excellent result (76%) compared to that of laminectomy (65%). They also noted a
tendency for patients treated with laminoplasty or laminectomy to deteriorate with time,
despite their initial clinical outcomes being comparable to that of anterior approaches 51.
Sampath, et al.,
52
performed a prospective outcome analysis study comparing medical
versus surgical treatment in patients with myelopathy. They demonstrated mixed results;
in the surgically treated group, they found a significant improvement in pain and
functional status, though no significant improvement in neurological outcome was
shown52.
Matz, et al.,
53
found that anterior cervical plating improved arm pain better than ACDF
alone in the treatment of 2-level disease (Class II). For 1-level disease, plating might
reduce the risk of pseudo-arthrodesis and graft problems (Class III) but did not improve
clinical outcome (Class II)
53
. Both ACDF with or without a plate are recommended as
19
UNIVERSITY OF NAIROBI
comparable treatment strategies (grade B), but a plate improves sagittal alignment (grade
B) 54 .
Kyphosis that occurs after dorsal cervical operations is prevalent, Steinmerts et al.,
55
study found it to occur in 21% of the patients and progressive kyphosis has been
observed in 53% of patients aged below 18 years who underwent multilevel
laminectomy54. Other notable complications include extent of posterior element
disruption leading to long term neck pain postop, compromised postoperative sagittal
balance and therefore chronic pain with unstable vulnerable neck, and the number and
location of lamina resected 53.
1.2.4.2 Complications of Surgery
All surgical procedures carry the inherent risk of complications. Early identification and
prompt management of these potential complications are imperative for achieving good
outcome in these patients
29
. All surgeons should be aware of his/her complication rate,
and thorough knowledge of previously reported complications is mandatory 29. The risks
associated with cervical spinal surgery depend upon the approach: anterior or posterior.
Marjorie, et al.,
34
found significant differences in complication associated with age,
primary diagnosis, and type of surgical procedure. Other surgical case series have
reported an increased number of complications after cervical spine surgery in elderly
patients compared to younger patients
19
and others have urged caution in operating on
elderly patients with myelopathy 21. However, few studies have addressed the effects of
patient characteristics and type of surgical procedure on complications and mortality in a
nationwide database 24.
20
UNIVERSITY OF NAIROBI
Fountas et.al.,
29
in a retrospective review study found out that the most common
complication was the development of isolated postoperative dysphagia, which was
observed in 9.5% of the patients. Postoperative hematoma occurred in 5.6%,
Symptomatic recurrent laryngeal nerve palsy occurred in 3.1% of the cases, dural
penetration occurred in 0.5%, esophageal perforation in 0.3%, worsening of preexisting
myelopathy in 0.2%, Horner's syndrome in 0.1%, instrumentation backout in 0.1%, and
superficial wound infection in 0.1% of the cases 29.
Romano, et al.,55 used ICD9 CM codes to evaluate elective cervical discectomy and
reported: 6.7% overall complication rate, 0.13% mortality , 0.03% cerebrospinal fluid
leak, 0.09% recurrent nerve palsy, 1.8% infection and <0.2% central nervous system
complication. In comparison, in the Nationwide Inpatient Sample
30
: infection was
documented in 0.11%; recurrent nerve palsy and hoarseness, 0.14%; cerebrospinal fluid
leak, 0.13% and central nervous system complication, 0.19%. Older age, a primary
diagnosis of cervical spondylosis with myelopathy, and a posterior or combined anterior
and posterior approach were significantly associated with a higher risk of a reported
complication 55.
21
UNIVERSITY OF NAIROBI
CHAPTER TWO
STATEMENT OF THE RESEARCH PROBLEM AND JUSTIFICATION
2.1 Statement of the Problem
Sub-Saharan Africa is known to bear a lopsided measure of the global burden of many
diseases and their attendant morbidities, including pain
56
. Among the factors that
amplify the prevalence of pain include; lack of access to health facilities, late
presentation, inadequate diagnosis, treatment unavailability and lack of medical
education regarding pain control among others
57
patients in their sunset years often die in pain
58
. In Kenya, studies reveal that many
. Assessing pain accurately and in a
culturally acceptable manner are crucial first steps to combating these pain management
challenges, both for pediatric and adult patients 57, 58.
Cervical spine diseases have a great significance and impact on neuroscience patients 59.
It is estimated that degenerative cervical spine disorders affects approximately two-thirds
of the population throughout their lifetime 60. Cervical DDD is a common condition. It is
often difficult to differentiate pathological changes from the normal aging process
61
.
While often benign and episodic in nature, cervical disorders may become disabling,
leading to severe pain and possibly neurologic sequelae. Degenerative cervical spine
disorders remain a common diagnosis in the general population and can be thought of in
terms of conditions causing axial pain, radicular complaints or findings of myelopathy.
Ongoing clinical trials and studies are helping to define the role of these new
technologies in treatment of patients with degenerative cervical disorders, although their
greater benefit has yet to be proven 61.
22
UNIVERSITY OF NAIROBI
With the management of cervical spine disorders having been revolutionized by the
advent of MRI scanning, there is need for the appropriate interpretation of these data
61
.
This interpretation shall always depend on the history and clinical (neurologic)
examination of the patients. Therefore, clinicians should have the necessary skills
required for the assessment of patients with spinal diseases
58
. Awareness on the
complications and clinical outcomes of neurosurgeries is important as it provides
valuable information on best outcomes of future surgeries. The aetiology of degenerative
disease of the spine is multifactorial, and examining each of the known risk factors
should help identify measures to limit or prevent the development of degenerative spinal
disease 59.
In patients with symptomatic cervical radiculopathy, arthroplasty achieves outcomes that
are equivalent to anterior cervical decompression and fusion, although evidence for
superiority is lacking. There is need for more prospective studies that will help define the
role and timing of surgical intervention in CSM and to determine the appropriate use of
cervical arthroplasty in the management of symptomatic cervical degenerative disc
disease 60.
This study will be conducted at Moi Teaching and Referral Hospital (MTRH), a tertiary
care referral centre in Eldoret, Kenya. It is the second National Referral Hospital in
Kenya and serves a referral population of close to 13 million people from Northern and
Western Kenya 62.
23
UNIVERSITY OF NAIROBI
2.2 Justification of the Study
Treatment of symptomatic cervical degenerative disease through surgery for patients with
spondylosis is a controversy issue in literature
63
. The natural course of symptomatic
cervical degenerative disease remains unclear, more so because no good quality,
prospective cohort studies of untreated patients have been conducted
61
. Many studies
contain lower complication rates because of incomplete records and recall bias
64
.
Retrospective reviews have been noted to significantly underestimate the overall
incidences of complications when used in spine surgery while prospective study of the
same report high complication rates
65
. Hopefully, the use of a prospective study in this
case is expected to contribute immensely in addressing the patterns and outcomes of
surgery for symptomatic degenerative disease of the cervical spine, an area not widely
researched in MTRH.
No similar study has been done to date in Kenya and therefore, the study will also greatly
contribute in determining the prevalence of symptomatic degenerative disease which will
act as a baseline/reference for future related studies.
2.3 Study Rationale
•
This study will act as a baseline and/ or reference study for other research studies on
local data on patterns and outcomes of treatment of cervical degenerative disc
diseases.
•
The findings of this study may be used for improvement of clinical outcome for
patients managed for symptomatic degenerative disc disease of the cervical spine.
24
UNIVERSITY OF NAIROBI
2.4 Aim and objectives of the study
2.4.1 Aim
The overall aim of this study was to describe the patterns and clinical outcomes
associated with surgery for symptomatic degenerative disc disease of the cervical spine at
the Moi Teaching and Referral Hospital, Eldoret.
2.4.2 Objectives
The specific objectives were to:
1. Describe the pattern and clinical presentation of cervical degenerative disc disease
among patients seen at MTRH.
2. Describe the clinical outcome associated with surgical treatment of symptomatic
cervical degenerative disc disease.
3. Determine the association between the clinical outcomes and patterns & type of
surgery.
25
UNIVERSITY OF NAIROBI
CHAPTER THREE
MATERIALS AND METHODS
3.1 Study Area
The study was carried out at the Moi Teaching and Referral Hospital in Eldoret Town
which is the second referral hospital in Kenya. The hospital is located within Eldoret
town which has an estimated population of over 200,000 residents as per the 2010 Kenya
demographic health survey.
3.2 Study Design
This was a prospective cross sectional study where patterns and clinical outcomes of
patients who underwent surgery for symptomatic degenerative disc disease of the cervical
spine were recorded.
3.3 Study Population
The study population comprised of all patients who were seen during routine clinical
work, diagnosed and subsequently underwent surgery for symptomatic degenerative disc
disease of the cervical spine after meeting the inclusion criteria. According to previous
MTRH database/records, an average of 45 surgeries involving degenerative cervical disc
disease is performed annually. This was used in the determination of sample size.
3.4 Sample Design and Procedure
3.4.1 Study period
The Study was carried out between October 2014 to May 2015.
26
UNIVERSITY OF NAIROBI
3.4.2 Sample Size Determination
The sample size was determined using the Fisher formula given below.
n=
Where;
n = desired sample size for population greater than 10,000.
= prevalence of most common pattern (C5/C6) of the cervical spine
involved.
Z = confidence level at 95% (corresponding to a standard Z value of 1.96)
q = 1- p
= level of significance (standard value of 0.05)
Therefore:

(1.96) 2 x0.5 x0.5
0.05 2
=
0.9604
= 384
0.0025
Since the target population was less than 10,000, finite population correction formula was
used to adjust the desired sample size.
nf =
n
1
n
N
Where
nf = the desired sample size for population less than 10,000.
n = the desired sample size (384)
27
UNIVERSITY OF NAIROBI
N = total population (target) < 10,000 (according to Hospitals’ statistics, on
average about 45 patients are discharged annually. Therefore:
nf =
=
384
384
1
45
384
= 40.3
9.53
Thus, desired sample size, n= 40
3.4.3 Inclusion Criteria
•
All patients who were seen during routine clinical work, diagnosed with cervical
degenerative disc disease, agreed to an informed consent and subsequently
underwent surgery of cervical spine as per the diagnosis.
3.4.4 Exclusion Criteria
• All patients who sustained cervical spine injury within the previous 6 weeks to the
study.
• Patients who had ongoing cervical infection.
• Patients who had cervical spine neoplasia.
• Patients who were unable to provide an informed consent including those in coma,
cognitively impaired and those critically ill.
28
UNIVERSITY OF NAIROBI
3.5 Data Collection Instruments and Techniques.
The main variables collected included patient biodata, risk factors, imaging findings,
indications for surgery, operative procedure done, post op complications and clinical
outcomes. Visual analog scale (VAS) is a psychometric response scale which can be used
in questionnaires. It is a measurement instrument for subjective characteristics or
attitudes that cannot be directly measured. It is the most common pain scale for quantification
and has superior metrical characteristics than discrete scales; therefore a wider range of
statistical methods can be applied to the measurements
67
. The Modified Rankin Scale
(MRS) is a commonly used scale for measuring the degree of disability or dependence in
the daily activities of people with neurological disability. Multiple studies have shown
that the MRS correlates with physiological indicators such as neurological impairment 68.
3.5.1 Data Collection Tools and methods
Data was collected using semi structured questionnaire. A semi-structured interviewer
administered questionnaire was used to obtain demographic data. Physical examination
of the patients was done and medical records as well as patients’ files reviewed. These
data were then entered into the semi structured questionnaire. The clinical outcomes were
assessed via Modified Rankin disability Scale (MRS) and Visual Analog Score for pain
(VAS).
29
UNIVERSITY OF NAIROBI
3.5.2 Actual Data Collection Phase
Socio-demographic variables such as age, gender and risk factors were collected from the
participants through an interview by the researcher with the aid of a standard
questionnaire. Imaging findings were assessed by the researcher with the assistance of the
supervisor. Post operative complications were examined for by the principle researcher in
the immediate post operative period. Clinical outcomes were assessed by the researcher
with the aid of a standard questionnaire. Subjects under study were explained to the
procedure and way of filling the VAS which was done preoperatively and l2 weeks post
operatively. MRS score was be filled by the researcher preoperatively and 12 weeks
postoperatively after clinical assessment of the subjects under study.
3.6 Data Analysis, Presentation and dissemination
The gathered data was confirmed for completeness, coded and then entered into a
computer using SPSS software version 19.0 and later exported to Cran R standard
package for statistical computing which was used for the analysis. Data analysis was
done using Cran R standard package for Statistical Computing. Data was summarized
using descriptive as well as the inferential methods. Descriptive statistics presented
included frequencies and the corresponding percentages for categorical variables; and
mean and the corresponding standard deviation (SD), as well as the median and the
corresponding inter quartile range (IQR) for continuous variables. Inferential statistics
presented were the paired t-test and the Wilcoxon sign rank test. The corresponding
statistics and p-values were provided. Gaussian assumptions were assessed using
Shapiro-Wilk test for normality. Results were presented using tables and graphs.
30
UNIVERSITY OF NAIROBI
Percentages were rounded up to the nearest whole number. Patient demographics,
symptoms and associated risk factors, imaging findings and indications for surgery were
done preoperatively. Surgical procedure done, post operative complications and
outcomes including VAS and MRS were analyzed postoperatively.
3.7 Ethical Considerations
3.7.1 Confidentiality
The researcher maintained maximum confidentiality for all information and data
presented by the respondents. All information collected on the patients were considered
confidential and treated as such. The instruments used for the research were void of the
patient’s names to ensure confidentiality.
Documents containing patient’s confidential information were put under lock and key
and not photocopied. The names of the patients or clinicians were similarly not recorded.
The information on the questionnaire was accessible only to the investigators and the
statistician. All information collected on the patients were considered confidential and
treated as such.
3.7.2
Ethical approval and termination of the study
The proposal was submitted to the MTRH ethics research review board (IREC) for
approval. The participants continued with the routine clinical review after being
terminated from the study 12 weeks post surgery. The study did not affect their clinical
management in any way.
31
UNIVERSITY OF NAIROBI
3.8 Limitations and delimitations
3.8.1 Limitations
1. Loss of patients to follow up
2. High cost of cervical implants may affect the ultimate procedure
3. Recall bias
3.8.2 Delimitations
1. Patient’s contacts were acquired for purposes of follow-up reminder.
2. Participants who couldn’t afford implants were offered acceptable alternative
procedure affordable to them.
3. Since patients could be biased in the symptomatology given, a standard
questionnaire was used to minimize the bias.
32
UNIVERSITY OF NAIROBI
CHAPTER FOUR: FINDINGS
4.1 FLOW CHART
Average number of patients operated
annually 45
Total Number of patients Operated on 44
Died at follow up 2
Total number of Patients followed up for
the study = 42
Figure 4.1: Flow Chart
An average of 45 patients with cervical degenerative disc disease were operated annually
at MTRH as per the hospital database. A total of Forty four patients were operated during
the period of the study out of which 42 were followed up for three months while two died
during follow up.
Table 4.1: Social Demographic characteristics
Variable
Age(years)
Female
Male
n (%) or Mean (SD)
56(13)
11(25%)
33(75%)
Occupation
Clerical
Doctor/Nurse
Driver
House wife
Manual labour
Sports
Farming
Teacher
Manual labour and farming
9(21%)
1(2%)
2(5%)
4(9%)
22(50%)
1(2%)
2(5%)
2(5%)
1 (2%)
33
UNIVERSITY OF NAIROBI
The mean age of the patients was 56 (±13) years. Thirty three patients (75%) were male.
Twenty three patients (52%) were doing manual labour while nine (21%) were doing
clerical work. The least associated occupation was doctor/ nurse as well as sportsmen,
each constituting one patient (2%) (Table 4.1).
Table 4.2: Symptoms Exhibited
Symptoms <6 months old
None
Lower Limb Weakness, Myelopathy, Neck pain, Paraethesia, Radiculopathy,
Upper limb weakness, Sphincter disturbance
Lower Limb Weakness, Myelopathy, Neck pain, Paraesthesia, Radiculopathy,
Upper limb weakness
Myelopathy
Myelopathy, Neck pain, Radiculopathy
Neck pain
Neck pain, Paraethesia, Radiculopathy
Neck pain, Radiculopathy
Paraethesia, Radiculopathy
Radiculopathy
Upper limb weakness
Symptoms > 6 months
None
Lower Limb Weakness, Myelopathy, Neck Pain, Paraesthesiae, Radiculopathy,
Upper limb weakness
Lower Limb Weakness, Myelopathy, Neck Pain, Paraesthesiae, Upper limb
weakness
Lower Limb Weakness, Myelopathy, Neck Pain, Radiculopathy, Upper limb
weakness
Myelopathy
Myelopathy, Neck Pain, Radiculopathy
Myelopathy, Parasthesia
Myelopathy, Parasthesia, Radiculopathy
Neck Pain, Parasthesia, Radiculopathy
Neck Pain, Radiculopathy
Neck Pain, Radiculopathy, Upper limb weakness
Parasthesia, Radiculopathy
Radiculopathy
n (%)
22 (50%)
2 (5%)
1 (2%)
1 (2%)
2 (5%)
3 (7%)
4 (9%)
4 (9%)
1 (2%)
3 (7%)
1 (2%)
16 (36%)
1 (2%)
1 (2%)
1 (2%)
1 (2%)
5 (11%)
1 (2%)
1 (2%)
8 (18%)
1 (2%)
1 (2%)
4 (9%)
3 (7%)
Among the symptoms exhibited for more than six months, a combination of neck pain,
paresthesia and radiculopathy was the commonest and reported by eight patients (18%).
34
UNIVERSITY OF NAIROBI
This was followed by a combination of myelopathy, neck pain and radiculopathy that was
present in five patients (11%). The commonest symptoms exhibited for less than six
months was a combination of neck pain, paresthesia and radiculopathy as well as
combination of neck pain and radiculopathy. These were reported by four patients (9%)
respectively. The second commonest symptoms exhibited for less than six months were
neck pain and radiculopathy that were reported by three patient (7%) respectively. The
rest of the occurrence of the symptoms are as shown in table 4.2. Overall combination of
Occurrence of symptoms for both less than and more than six months are as shown in
figures 4.2 and 4.3 respectively.
35
UNIVERSITY OF NAIROBI
Fig
ure 4.2: Overall occurrence of a combination of symptoms for a duration less than 6
months
36
UNIVERSITY OF NAIROBI
Figure 4.3: Overall Occurrence of a combination of symptoms for duration more
than 6 months
Table 4.3: Associated factors
Variable
Family history of degenerative disc
disease
Person in the family
Extended family
Nuclear family
History of previous neck trauma
Alcohol intake
Smoking
n (%)
9(21%)
7(78%)
2(22%)
28(64%)
18(41%)
16(36%)
Previous history of trauma to the neck was present in twenty eight patients (64%).
Eighteen (41%) had history of alcohol use while sixteen (36%) had history of cigarette
smoking.
37
UNIVERSITY OF NAIROBI
Family history of degenerative disc disease was present in nine patients, (21%). Amongst
them, seven (78%) reported extended family members while two, (22%) reported nuclear
family members.
Table 4.4: Comorbidities
Comorbidity
None
Diabetes
Diabetes and Osteoarthritis
Osteoarthritis
Osteoarthritis and Rheumatoid arthritis
n (%)
35 (80%)
2(5%)
1 (2%)
5(11%)
1(2%)
Comorbidities such as diabetes, rheumatoid arthritis, and osteoarthritis were reported
among the patients. The commonest was osteoarthritis seen in seven patients, (15%)
followed by diabetes mellitus reported by three patients, (7%) while rheumatoid arthritis
was present in one patient, (2%). Thirty five patients (80%) did not have associated
comorbidities (Table 4.4).
Table 4.5: Imaging findings/ Disc level affected
Level
C3/C4
C4/C5
C5/C6
C6/C7
C3/C4, C4/C5
C4/C5, C5/C6
C4/C5, C6/C7
C5/C6, C6/C7
C2/C3, C3/C4, C4/C5
C3/C4, C4/C5, C5/C6
C4/C5, C5/C6, C6/C7
C3/C4, C4/C5, C5/C6, C6/C7
n (%)
3 (7%)
5 (11%)
13 (30%)
3 (7%)
4 (9%)
7 (16%)
1 (2%)
2 (5%)
1 (2%)
3(7%)
1 (2%)
1 (2%)
Thirteen patients, (30%), had C5/C6 disc level affected. Five (11%) had C4/C5 disc
affected while three patients (7%) had C3/C4 level affected. no patient was found to have
38
UNIVERSITY OF NAIROBI
C2/C3 alone affected. Twenty four patients (55%) had a single level disease while twenty
(45%), had multiple disc levels affected out of which fourteen (32%) had two disc levels
affected, five (11%) with three discs levels affected while one patient (2%) had four discs
levels affected.
Overall, the single most common disc level affected was C5/C6 with twenty seven
patients (61%), followed in order of decreasing frequency by C4/C5 seen in twenty three
patients (52%), C3/C4 in twelve patients (27%), C6/C7 in eight patients (18%) and
C2/C3 seen in only one patient(2%) (Figure 4.4).
Figure 4.4: disc level affected
39
UNIVERSITY OF NAIROBI
Table 4.6: Indications for surgery
Indication
n (%)
Severe pain/ radiculopathy
Severe weakness
Myelopathy
Myelopathy, severe weakness
Myelopathy, severe pain/radiculopathy
Myelopathy, severe pain/radiculopathy, Severe weakness
Myelopathy, severe pain/radiculopathy, Severe weakness, Sphincter anomaly
Failed conservative management
Failed conservative management, severe pain/radiculopathy
Failed conservative management, Myelopathy, Severe pain/radiculopathy
Failed conservative management, Myelopathy, severe pain/radiculopathy, severe
weakness
10 (23%)
1 (2%)
1 (2%)
2 (5%)
4 (9%)
3 (7%)
1 (2%)
1 (2%)
16 (36%)
4 (9%)
1 (2%)
The main indication for surgery was failed conservative management with severe pain/
radiculopathy that was reported by sixteen patients (36%). This was followed by severe
pain/radiculopathy that was reported by ten (23%) of the patients. Other indications
included severe weakness, myelopathy, failed conservative management, and sphincter
anomaly that was observed in eight (18%), sixteen (36%), twenty two (50%), and one
patient (2%) respectively. The combinations of the occurrence of these indications were
as shown in Table 4.6.
40
UNIVERSITY OF NAIROBI
Table 4.7: Disease Level and Operative procedure done
Characteristic
ACDF levels
n (%)
C3/C4
C4/C5
C5/C6
C6/C7
C3/C4, C4/C5
C4/C5, C5/C6
C4/C5, C6/C7
C5/C6, C6/C7
C2/C3, C3/C4, C4/C5
C3/C4, C4/C5, C5/C6
C4/C5, C5/C6, C6/C7
C3/C4, C4/C5, C5/C6, C6/C7
Procedure done
ACDF with Cage only
ACDF with cage and Plate
Autologous bone graft
Pyramesh cage
Cervical laminectomy
Number of levels
Single level (n=24, 55%)
3 (7%)
5 (11%)
13 (30%)
3 (7%)
4 (9%)
7 (16%)
1 (2%)
2 (5%)
1 (2%)
3 (7%)
1 (2%)
1 (2%)
7 (16%)
30 (68%)
4 (9%)
1 (2%)
2 (5%)
Procedure Done
ACDF with Cage only
ACDF with cage and Plate
Autologous bone graft
n (%)
6 (25%)
14 (58%)
4 (17%)
Two level (n=14, 32%)
ACDF with Cage only
ACDF with cage and Plate
Cervical laminectomy
1 (7%)
11 (79%)
2 (14%)
Three level (n=5, 11%)
ACDF with cage and Plate
5 (100%)
Four level (1, 2%)
Pyramesh
1 (100%)
The commonest procedure done irrespective of the number of levels of disease was an
ACDF with cage and plate. This was done in fourteen (58%) of the single level disease,
eleven (79%) of the two level disease, all five (100%) of the three level disease as well as
the participant with four level disease who had a pyramesh. Two patients (5%) had a
cervical laminectomy. Other procedures done for the different level of disease are as
shown in Table 4.7.
41
UNIVERSITY OF NAIROBI
Table 4.8: Clinical Outcomes
Outcome measure score
Visual Analog Score
(VAS)
MRS
Median (IQR)
6 (5 to 7)
12 weeks
Post-operative
n = 42
Median (IQR)
2 (1 to 3)
Post – Pre operative
score
n = 42
Median (IQR)
-4 (-5, to -3)
3 (2 to 3)
1 (0 to 1)
-2 (-2 to -2)
Pre-operative
n = 44
Clinical outcomes were assessed on two scales; the Visual Analog Score for pain (VAS)
and the Modified Rankin Scale (MRS).The median pre and post operative scores as well
as the difference in the scores were calculated (Table 4.8). Their subsequent distributions
were graphed (Figure 4.5 and figure 4.6). A significance test on the difference using a
one sample t-test showed the twelve week postoperative scores to be significantly lower
than preoperative scores (p<0.0001) (Figure 4.5).
42
UNIVERSITY OF NAIROBI
Figure 4.5: Distribution of Pre and Post-Operative VAS scores, together with the
differences
Figure 4.6 shows the distribution of MRS pain scores pre-operation and twelve weeks
post operation. Before surgery, the median MRS scores was 3 (IQR: 2 to 4) while the
median MRS post-surgery pain score was 1 (IQR: 0 to 1). The distribution of MRS score
post-surgery was skewed with median equal to the upper quartile. This shows that most
43
UNIVERSITY OF NAIROBI
(over 75%) of the participants had post-surgery MRS pain score that was equal to 1. The
significance test was conducted using the non-parametric analogue of the paired t-test.
This is the Wilcoxon sign rank test. The results showed that the post-surgery MRS pain
score significantly reduced compared to before surgery (p<0.0001).
Figure 4.6: Distribution of Pre- and Post-operative MRS scores together with the
differences.
44
UNIVERSITY OF NAIROBI
Table 4.9: Relationship between VAS score outcome and different operative
procedures
Number of levels
₮
Single level
(n=24)
Procedure Done
n
ACDF with Cage only
ACDF cage and Plate
Autologous bone graft
6
14
4
ACDF Cage only
ACDF cage and Plate
Cervical laminectomy
ACDF cage and Plate
Pyramesh
1
11
2
5
1
Two level (n=14)
Three level (n=5)
ħ
Four level (n=1)
Pre-operative VAS
score
Median (IQR)
6.0 (5.0 – 7.0)
Post-operative VAS
score
Median (IQR)
2.0 (1.0 – 2.5)
6.0 (5.3 – 6.8)
6.5 (6.0 – 7.0)
5.0 (4.8 – 5.5)
6.0 (5.3 – 7.0)
9.0
6.0 (5.5 – 7.0)
8.0 (4.0 – 8.0)
8.0 (4.0 – 8.0)
7.0
1.0 (1.0- 1.0)
2.0 (2.0 – 3.0)
0.5 (0.0 – 1.8)
2.0 (1.0 – 3.0)
1.0
2.0 (1.0 – 3.0)
3.0 (2.0 – 4.0)
2.0 (2.0 – 4.0)
-
₮ - Post operative procedure VAS score was observed for 23 participants only (i.e. among 13 who underwent cage and
plate procedure), ħ – No Post -operative procedure VAS score was observed for the participant.
The commonest procedure done irrespective of the number of levels of disease was
ACDF with cage and plate. The median preoperative as well as postoperative VAS and
MRS score amongst patients who underwent the different procedures are as shown (Table
4.9 and 4.10).
Table 4.10: Relationship between MRS score and different operative procedures
Number of levels
Procedure Done
₮
Single level (n=24)
ACDF Cage only
ACDF cage and Plate
Autologous bone graft
Two level (n=14)
ACDF Cage only
ACDF cage and Plate
Cervical laminectomy
Three level (n=5)
ACDF cage and Plate
ħ
Four level (n=1)
Pyramesh
n
6
14
4
1
11
2
5
1
Pre-operative
MRS score
Median (IQR)
2.0 (2.0 – 3.0)
2.0 (2.0 – 2.8)
2.0 (2.0 – 3.0)
2.5 (2.0 – 3.0)
3.0 (3.0 – 3.0)
3.0 (3.0 – 3.0)
3.0 (3.0 – 3.5)
3.0 (3.0 – 3.0)
4.0 (4.0 – 4.0)
5.0 (5.0 – 5.0)
Post-operative MRS
score
Median (IQR)
1.0 (0.0 – 1.0)
0.0 (0.0 – 0.8)
1.0 (0.0 – 1.0)
0.5 (0.0 – 1.0)
1.0 (0.0 – 1.0)
1.0 (1.0 – 1.0)
1.0 (0.0 – 1.0)
0.5 (0.3 – 0.8)
2.0 (2.0 – 2.0)
-
₮ - Post operative procedure MRS score was observed for 23 participants only (i.e. among 13 who underwent cage and
plate procedure), ħ – No Post -operative procedure MRS score was observed on the participant.
45
UNIVERSITY OF NAIROBI
Table 4.11: Association between the baseline characteristics and the outcome
Variable
Age (years)
<50 (n=16)
51-70 (n=18)
>70 (n=8)
Sex
Female (n=11)
Male (n=31)
Change in VAS score
Change in MRS score
Median (IQR)
P
Median (IQR)
P
-5.5 (-7.0, -3.8)
-4.0 (-4.0, -3.0)
-3.5 (-4.0, -2.0)
0.018
-2.0 (-3.0, -2.0)
-2.0 (-2.0, -1.0)
-2.0 (-2.3, -2.0)
0.217
-5.0 (-7.0, -4.0)
-4.0 (-4.0, -3.0)
0.035
-2.0 (-3.0, -2.0)
-2.0, -2.0, -1.5
0.289
Occupation
Clerical, Doctor/Nurse,
Driver, House wife, or
teacher (n=17)
-4.0 (-5.0, -3.0)
-2.0 (-2.0, -2.0)
0.505
0.529
Manual labour, Sports, or
farmer (n=25)
-4.0 (-6.0, -3.0)
-2.0 (-2.0, -1.0)
Comorbidities
No (n=33)
Yes (n=9)
-4.0 (-6.0, -3.0)
-4.0 (-4.0, -2.0)
0.088
-2.0 (-3.0, -2.0)
-2.0 (-2.0, -1.0)
0.085
Post Operation
complications
No (n=35)
Yes (n=7)
-4.0 (-5.0, -3.0)
-4.0 (-6.5, -4.0)
0.095
-2.0 (-2.0, -1.0)
-2.0 (-3.0, -2.0)
0.101
There was significant differences in the VAS score outcome measure across the age
groups, p=0.018, as well as by gender, p=0.035. The elderly had smaller change
compared to the younger patients. Male participants had significantly lower change
compared to female.
The correlation between the number of symptoms and the change in VAS, r = 0.15,
p=0.329, was statistically non-significant. However, there was a trend towards better
outcome among those who had more symptoms.
46
UNIVERSITY OF NAIROBI
Similarly, the correlation between the number of symptoms and the change in MAR, r =
0.04, p=0.782, was statistically non-significant but with a trend towards better outcome
among those who had more symptoms.
Table 4.12: Outcome by the levels of disease
Level of disease
Change in VAS
Change in MRS
C2/C3 (n=1)
C3/C4 (n=11)
C4/C5 (n=22)
C5/C6 (n=25)
C6/C7 (n=7)
-7.0
-4.0 (-4.5, -3.0)
-4.0 (-5.0, -3.0)
-4.0 (-4.0, -3.0)
-3.0 (-5.0, -3.0)
-3.0
-2.0 (-2.5, -1.0)
-2.0 (-2.0, -2.0)
-2.0 (-2.0, -2.0)
-2.0 (-2.5, -1.0)
The correlation between the number of levels of diseases and the change in VAS, r =
0.09, p=0.557, was statistically non-significant. However, there was a trend towards
better outcome among those who had more levels of disease.
Similarly, the correlation between the number of levels of disease and the change in
MRS, r = -0.355, p=0.029, was statistically not significant showing that participants with
more levels of disease affected were associated with bad outcome.
47
UNIVERSITY OF NAIROBI
Table 4.13: Post-operative Complications
Complication
None
Dysphagia and Neck Pain
Dysphagia and Post-operative haematoma
Neck pain
Post-operative haematoma
Dysphagia and death from aspiration pneumonia
Death from PTE
Vascular injury
n (%)
35(80%)
1(2%)
2(5%)
3(7%)
1 (2%)
1(2%)
1 (2%)
0 (0%)
Thirty five patients (80%) had no post-operative complications. Among the patients who
had post-operative complications, the commonest was neck pain that was reported by
three patients (7%). This was followed by dysphagia and post-operative haematoma that
was reported by two patients (5%).Other complications reported are as shown in table
4.13.
48
UNIVERSITY OF NAIROBI
5.0 DISCUSSION
5.1 Discussion
This study described the patterns and clinical outcomes of surgically treated cervical
spine degenerative disc disease among 44 patients on routine follow up at the Moi
Teaching and Referral Hospital. It was observed that majority of the participants were
working class population. The mean age was 56 ± 13 years with the range between 34 to
81 years. The occurrence of CDDD in a younger age group in the study therefore could
be due to the fact that the younger and working population superseded the elderly
population (KDHS
10
). Younger patients were also more predisposed to risk factors as
87% of manual labourers as well as 89% of those with previous history of neck trauma
were less than sixty years old. Jäger et al. 27 also, in a case control study in Ghana found
that axial strain of carrying load on the head exacerbates degenerative change in the
cervical spine, with consecutive narrowing of the medullary canal. This indicates a similar
pathophysiologic mechanism. In the developed countries however; the rate of growth of
the elderly population supersedes that of the entire population (De Kleuver M et al. 8) and
an increase in the prevalence of CDDD with aging has been noted (Kellgren JH et al. 13).
The difference in lifestyle between our study and the developed countries could explain
the increased prevalence of CDDD in a younger population (Degefe A et al.16). It could
also be due to the fact that cervical vertebrae of whites are significantly more affected
than their black counterparts (Taitz C et al.
28
) perhaps as a result of racial difference
between the two populations. Male patients constituted 75% while female were 25%
giving a male to female ratio of 4:1. These findings show that the condition was four
49
UNIVERSITY OF NAIROBI
times more prevalent among males as compared to their female counterpart. The higher
occurrence in the male participants may be attributed to the fact that 91% of manual
labourers, 86% of patients with previous history of neck trauma as well as all patients
(100%) with history of cigarette smoking were male. These findings contradict those of
Fisher et al. 31, which established the incidence rate for males as equal to that of female.
This could be due to the fact that there was no identifiable difference in the risk factors in
both male and female patients in the Fisher et al. study. It could also be attributed to the
difference in occupation of the patients, the difference in the mean age of the participants
between our study and that of fisher et.al as well as the race and geographical differences
as the study was conducted in New York while the current study was conducted in
Eldoret, Kenya which is an agricultural and industrial town in a developing country.
52% of the patients in the study were doing manual labour, 21% were doing clerical
work, 9% were housewives, 5% were drivers, farmers and teachers whereas doctor/ nurse
and sportsperson constituted 2% of the patients. Manual labour exposes the intervertebral
discs to mechanical stress leading to altered biomechanics and therefore a higher risk of
undergoing degenerative changes faster (Jayme et al. 9, Degefe A et al. 16, Gore, D.R. et
al. 22). These findings contradict those of Fineberg, Oglesby, and Patel 5 who established
that the educated populace was at a greater risk of degenerative cervical spine disorders.
The difference could be attributed to the fact that doctors and nurses were more educated
as compared to manual labourers and therefore seek medical attention before further
progression of the disease. The difference could also be attributed to the difference in the
50
UNIVERSITY OF NAIROBI
occupations associated with the predisposition to cervical degenerative disc disease as
doctors and nurses are less involved in manual labour.
Among the patients who presented with symptoms for less than six months,
radiculopathy was the commonest with 39% of the patients affected. This was followed
by neck pain that was exhibited by 36 % of the patients, 18% had paraesthesia, 14% had
myelopathy, 9% had upper limb weakness, 7% had lower limb weakness whereas
sphincter disturbance was present in 5% of the patients. Among patients who presented
with symptoms for more than six months; radiculopathy was the commonest with 57% of
the patients, Myelopathy with 25%, upper limb weakness with 9%, and lower limb
weakness with 7% of the patients affected. This study demonstrated similarity in
symptomatology to that done by Ferdinandov et al.12, who demonstrated that the
commonest presenting symptoms were radiculopathy of upper limbs, myelopathy as well
as neck pain. This could be attributed to similar pathophysiologic processes for cervical
DDD due to similarity in the associated risk factors that included previous history of neck
trauma, mechanical factors as well as cigarette smoking.
The commonest factor associated with cervical degenerative disc disease in the study was
prior history of trauma to the neck that was seen in 64% of the patients. This was
followed by alcohol intake that was present in 41%, cigarette smoking in 36% and
Family history of degenerative disc disease in 21% of the patients amongst whom 78%
reported extended family members while 22% reported nuclear family members.
The commonest associated co morbidity was osteoarthritis that was seen in 16% of the
patients. 7% of the patients had diabetes mellitus while rheumatoid arthritis was seen in
51
UNIVERSITY OF NAIROBI
2% of the patients. 80% of the patients did not have associated co morbidity. Ferdinandov
et al. 12, also demonstrated underlying associated factors for CDDD. Among the genetic
factors that were associated with degenerative CDD included co morbidities e.g.
osteoarthritis and rheumatoid arthritis that affect the integrity of connective tissues that
are also present in intervertebral discs. Acquired predisposing factors included cigarette
smoking and trauma to the neck that are known to affect the integrity of connective
tissues as well as alteration of the biomechanical properties of the cervical spine
respectively. Jäger et al. 27 also, in a case control study, concluded that axial strain of
carrying load on the head as seen in manual laborers exacerbates degenerative changes in
the cervical spine.
The most commonly affected intervertebral disc was C5/C6 that was seen in 30% of the
patients. 11% had C4/C5 disc affected while 7% had C6/C7 and C3/C4 discs affected.
The least affected intervertebral region included C3/C4 (10%) and C2/C3 (0%). 45% of
the patients had multiple discs affected out of which 70% had two levels affected, 25%
had three levels affected and 5% had four disc affected.
Overall, 2%, 27%, 52%, 61%, and 18% of the participant had discs C2/C3, C3/C4,
C4/C5, C5/C6, and C6/C7 affected, respectively. According to a study done by Lestini
and Wiesel et al.
25
, the most common affected discs and nerve roots are as follows in
order of decreasing frequency: C5/C6 disc, C6 root; C6/C7 disc, C7 root; C4/C5 disc, C5
root; C3/C4 disc, C4 root; C7/T1 disc, C8. We demonstrated similar findings like Lestin
and Wiesel as regards the single most common disc level affected. The similarity may be
because C5/C6 level has the greatest decrease in sagittal diameter; it controls most
52
UNIVERSITY OF NAIROBI
flexion and extension movements in the neck with the spinal canal being narrowest at this
level hence more vulnerable than other levels (Gore D.R et al. 22, Robinson R.A et al. 23).
Subsequent levels affected however differed and this may be due to the difference in the
predisposing factors as well as the difference in the population characteristics including
the race and age as the population in the study by Lestin and Wiesel 25 was older than our
population (mean 56 years Viz a viz 74 years) whereas manual labour and trauma was the
commonest in our study.
Overall, the main indication for surgery in the study was severe pain/radiculopathy that
was reported by 89% of the patients. Other indications included; failed conservative
management, severe myelopathy, weakness of upper and lower limbs and sphincter
anomaly that was observed in, 50%, 36%, 18% and 2% of the participants respectively.
Williams K et al. 24, recommended surgery for CDDD in patients having axial neck pain
with failure of 6 to 12 months of conservative management, those with persistent
radiculopathy unresponsive to 6 to 12 week of trial of conservative management as well
as progressive myelopathy. Fouyas IP, et al.
29
, recommended surgical treatment in
patients with severe myelopathy. Our recommendation was therefore similar to other
studies.
Anterior procedures constituted 95% of the operative approach in the study. This is
because majority of the pathology was anterior with anterior compression of the cervical
spinal cord as well as narrowing of the exit foraminae. 5% of the participants underwent a
posterior approach. Among participants with single level disease, the commonest
procedure done was ACDF with cage and plate (58%). The patients had cord
53
UNIVERSITY OF NAIROBI
compression with myelomalacia and stenosis of exit foraminae as well as loss of lordosis
and could afford to buy the implants. 25% had ACDF with cage only having presented
with failed conservative management, severe pain, with normal lordosis and no cord
compression. 17% had an ACDF with autologous tricortical iliac crest bone graft after
presenting with severe pain and radiculopathy and were unable to afford implants.
The commonest procedure amongst participants with two level disease was ACDF with
cage and plate (79%). This was done in young active patients who presented with severe
pain/ radiculopathy, myelopathy and failed conservative management with predominant
anterior cord compression. 14% had two level cervical laminectomy. These were elderly
patients with associated co morbidities i.e. 78 and 81 years old, diabetic and with
osteoarthritis, had severe myelopathy and canal stenosis presenting as inability to walk
and sphincter abnormalities. MRI confirmed two level disease each (C3/C4, C4/C5 and
C4/C5, C5/C6) with canal stenosis. 7% underwent an ACDF with cage only having being
a young teacher and presented with severe radiculopathy with normal lordosis and
without cord compression. All patients with three level disease underwent ACDF with
cage and plate because the disease was extensive i.e. more than two levels and with
severe myelopathy and loss of the normal cervical lordosis. The single subject with a four
level disease underwent an anterior cervical corpectomy and pyramesh cage insertion
having had a previous history of trauma to the neck with severe myelopathy, upper and
lower limb weakness with multiple vertebral body collapse and loss of lordosis. Patient
could also afford the implants.
54
UNIVERSITY OF NAIROBI
There were two measures of outcome used in the study. The visual analogue score (VAS)
used as an outcome with regards to pain as well as the modified Rankin Scale (MRS)
used to assess post operative disability. This was due to their relative simplicity and
usability (Reips et. al
67
, Wilson JL et al
68
). The visual analogue score showed that the
median preoperative score for pain was 6 (IQR: 5 to 7) while the twelve week postoperative pain score was 2 (IQR: 1 to 3). The median difference in the pain score (twelve
week post-operative pain score minus preoperative pain score) was -4 (IQR: -5, to -3)
(Table 4.8). The distributions for the preoperative, twelve week postoperative scores as
well as the difference were graphed (figure 4.5). Note that the scores range from 0 to 10.
However, the graph shows that the y axis runs from -8 to 9. This is to help us compare
the observed scores (pre and post operative) and see how they compare on the same scale
with the difference (Imagine the distribution of the difference was positive!). The
distributions did not seem to violate the normality assumption, particularly the difference
between the two scores. Thus to compare the twelve week post-operative scores to the
preoperative scores, a significance test on the difference was done using a one sample ttest which is similar to doing a paired t-test. The results showed that the twelve week
postoperative scores were significantly lower than preoperative scores (p<0.0001). This
implies that surgical intervention was generally beneficial in that it led to a statistically
significant reduction in pain threshold from the dreadful level pre operatively to the
annoying level three months post operatively.
Before surgery, the median MRS scores was 3 (IQR: 2 to 4) while the median MRS postsurgery pain score was 1 (IQR: 0 to 1) (Table 4.8). The distribution of MRS score post55
UNIVERSITY OF NAIROBI
surgery was skewed with median equal to the upper quartile. This shows that most (over
75%) of the participants had post-surgery MRS disability score that was equal to 1
(Figure 4.6). The significance test was conducted using the non-parametric analogue of
the paired t-test. This is the Wilcoxon sign rank test. The results showed that the postsurgery MRS disability score significantly reduced compared to before surgery
(p<0.0001). Clinically, this means that preoperatively, most subjects had moderate
disability and required some help to carry out their usual chores. They significantly
improved three months Post operatively, and were able to carry out all usual duties and
activities. We demonstrated favorable outcomes as seen in other studies (Yonenobou et
al.
51
, Loembe et al.
50
, Matz, et al.
53
). The favorable outcomes could be attributed to
proper patient selection and the correct surgical procedure done.
Participants were stratified into those less than 50 years old, 51- 70 years and more than
70 years old. Majority of the participants were between 51 to 70 years of age, n= 18.
There was significant difference in the VAS score measured across the age groups,
p=0.018. Generally, older participants had less change compared to their younger
counterpart. This means younger patients had better improvement of pain than their older
counterparts. The improvement in the degree of disability, irrespective of the age was
similar three months post operatively. The difference in pain improvement may be
attributed to the slow rate of recovery as well as the high probability of wear and tear
associated with old age. It could also be attributed to the difference in the operative
approach as two elderly participants underwent a posterior approach that has been shown
to have a tendency to deteriorate with time despite initial comparable results (Yonenobou
56
UNIVERSITY OF NAIROBI
et al.51). An increased number of complications was reported after cervical spine surgery
for DDD in elderly compared to younger patients (Baron et al. 66). Similar findings were
also observed by Marjorie et al.
34
who noted significant differences in outcome
associated with age (less favourable outcome with increasing age), primary diagnosis and
type of surgical procedure. The increase in complication associated with CDDD after
surgery in the elder may be due to relative slow rate of recovery in the elderly, fragile
tissues associated with wear and tear with poor recovery rate as well as association with
other co morbidities.
There was significant difference in the VAS score across gender, (p=0.035). Male
participants had significantly lower change three months post operatively compared to
the females. This implies that female participants had better improvement of pain post
operatively though the difference was statistically not significant (p=0.035). The change
in MRS disability score was similar among all gender three months post operatively
(p=0.289). Clinically, this mean the improvement in the degree of disability state three
months post operatively was similar irrespective of the gender. The better improvement
of pain in female patients may be attributed to the difference in occupation and
predisposing factors as most male patients were manual labourers and involved in
traumatic events as compared to the female. Also, the duration of symptoms and different
degree of pain threshold at presentation as well as the tendency of male patients to
present with multiple level disease. The study contradicts that done by Peolsson A et
al.48, who demonstrated that after cervical spine surgery, health status tended to be worse
in women than in men. The difference in outcome could be as a result of the difference in
57
UNIVERSITY OF NAIROBI
operative procedures done, genetic difference as well as presence of co morbidities as
most female patients had similar predisposing factors to the males in the Peolsson et al.
study.
The difference in the VAS pain score was equal amongst clerks, doctors/ nurses, drivers,
housewives and teachers, -4 (-5.0, -3.0), as well as manual laborers, sportsmen and
farmers, -4 (-6.0, -3.0), p= 0.505. Clinically, this means that there was an equal threshold
of improvement of pain three months post operatively across all the occupation.
Similarly, there was equal difference in MRS disability score across all the occupations 2.0, p=0.529 meaning the degree of disability improved two folds three months post
operatively irrespective of the associated occupation. This finding can be attributed to the
similarity in severity and duration of symptoms at presentation as well as proper surgical
indication and procedure for the specific patient.
The Spearman rank correlation method was used to determine the correlation
coefficience. Subsequently, a one sample t-test was conducted to assess the significance
of the correlation coefficience. The correlation between the number of symptoms and the
change in VAS, r = 0.15, p= 0.329, was statistically non-significant. There was however
a trend towards better outcome among those who had more symptoms. Clinically, this
means that participants who presented with multiple symptoms showed a trend towards
better outcome in pain management post operatively.
Similarly, the correlation between the number of symptoms and the change in MRS, r =
0.04, p=0.782 was statistically non-significant though clinically, there was a trend
58
UNIVERSITY OF NAIROBI
towards better outcome among those who had more symptoms. The better results seen in
patients presenting with more symptoms may be due to multiple level involvement with
severe symptoms that corrected after surgery with decompression and restoration of
cervical spine alignment.
As shown in table 4.9 and 4.10, there were six patients (25%) with single level disease
who underwent ACDF with cage only. Their median pre op VAS pain score was 6.0 (5.36.8) and a three month post op VAS score of 1.0 (1.0- 1.0). Their pre and post operative
MRS score was 2.0 (2.0- 2.8) and 0.0 (0.0- 0.8) respectively.
Fourteen patients (58%) had single level disease and underwent an ACDF with cage and
plate. Their median preoperative VAS score was 6.5 (6.0- 7.0) and a three month post
operative VAS score of 2.0 (2.0- 3.0). Their pre as well as post operative median MRS
scores were 2.0 (2.0- 3.0) and 1.0 (0.0- 1.0) respectively.
Four patients (17%) had a single level disease and underwent an ACDF with autologous
tri cortical iliac crest graft. Their median pre operative VAS pain score was 5.0 (4.8- 5.5)
and the three month post operative VAS score was 0.5 (0.0- 4.8). Consequently, their pre
and post operative median MRS score was 2.5 (2.0- 3.0) and 0.5 (0.0- 1.0) respectively.
There were fourteen patients with a two level disease. One (7%) underwent an ACDF
with cage only. The median preoperative VAS score was 9.0 and a three month post op
VAS score of 1.0. The pre operative MRS score was 3.0 (3.0- 3.0) and post operative
MRS score of 1.0 (1.0- 1.0). Eleven Patients (79%) with two a level disease underwent an
ACDF with cage and plate. Their median pre operative VAS pain score was 6.0 (5.559
UNIVERSITY OF NAIROBI
7.0) and three month post operative VAS score of 2.0 (1.0- 3.0). The pre operative
median MRS score was 3.0 (3.0- 3.5) and a three month median post operative MRS
score of 1.0 (0.0- 1.0).
There were two patients (14%) with a two level disease who subsequently underwent
cervical laminectomy. They had a median pre operative VAS score of 8.0 (4.0- 8.0) and a
median three month post op VAS score of 3.0 (2.0- 4.0). The median pre operative MRS
score was 3.0 (3.0- 3.0) and post operative MRS score of 5.0 (0.3- 0.8).
All the five patients with a three level disease underwent an ACDF with cage and plate.
Their median pre op VAS score was 8.0 (4.0- 8.0) and a three month post op VAS score
of 2.0 (2.0- 4.0). Consequently, their median pre operative MRS score was 4.0 (4.0- 4.0)
and post operative MRS score of 2.0 (2.0- 2.0)
There was one patient (100%) with a four level disease who underwent a three level
corpectomy and pyramesh cage insertion. The median pre op VAS score was 7.0. The
median pre operative MRS score was 5.0 (5.0- 5.0). However, the participant died on
post operative day three due to pulmonary embolism confirmed at autopsy.
This study therefore demonstrated that across all the patients presenting with different
levels of disease, there was significant improvement in the degree of pain three months
post operatively as well as significant improvement on the degree of disability three
months post operatively. This means that surgical intervention was significantly
beneficial clinically irrespective of the number of levels of disease affected as well as the
operative procedure done (whether anterior or posterior, with artificial implants or
60
UNIVERSITY OF NAIROBI
autologous bone graft). This is irrespective of the two participants who died during
follow up. The use of cervical plate either, did not alter clinical outcome post operatively
irrespective of the number of level of disease operated. Other studies have also
demonstrated improvement in outcomes after surgery; In Gabon, Loembe et al.50 reported
complete neurologic recovery in 56 %, partial recovery in 39 % and unchanged status in
6% of the patients after undergoing an anterior approach. Matz et al.53, demonstrated
improved arm pain with anterior cervical plating better than ACDF in the treatment of a
two level disease. The clinical outcomes where however not improved with single level
disease. They concluded that both ACDF with and without a plate are recommended as
comparable treatment strategies but a plate improved sagittal alignment. Klein et al.49, in
their prospective assessment found favorable outcomes after one or two level ACDF for
CDDD in patients presenting with radiculopathy. Yonenobou et al.51, studying CDDD
with myelopathy found that anterior approaches had good to excellent results compared
to posterior approaches. Sampath P et al.53, however, in a prospective outcome analysis
study demonstrated mixed results. They found a significant improvement in pain and
functional status, though no significant improvement in neurologic outcome. Other
studies on the contrary showed unfavorable outcomes with ACDF and therefore in
contradiction to our outcomes; Peolsson A et al.48, generally reported unfavorable
outcome in the neck specific function, poor health related quality of life, and physical
deficits displayed by a third of the patients e.g. reduced neck and hand muscle strength on
an average of six year follow up. Our study is also in contrary to that by Anneli Peolsson
et al.33, who demonstrated that two thirds of their participants reported high intensity
61
UNIVERSITY OF NAIROBI
neck pain; psychological distress and poor general health on an average of three year
follow up. The difference in the outcomes of the studies could be attributed mainly to the
difference in population characteristics, operative procedures done as well as the duration
of follow up as our study did a three month follow up whereas the other studies did a
longer duration follow up e.g. Peolsson and Kjellman 48 follow up duration was six years.
Post operative complications were observed among 20% of the patients. The commonest
post operative complication was neck pain (9%), followed by dysphagia and postoperative haematoma that was seen in 7% of the patients. 5% of the patients died during
follow up. The cause of death was confirmed at autopsy to be pulmonary embolism at
post operative day three (58 year old male patient with four level disease, underwent
three level corpectomy and pyramesh insertion, had no immediate post operative
complications) and aspiration pneumonia on post operative day five (62 year old male
patient with two level disease who underwent ACDF with cage and plate). Fouyas IP et
al.29, in a retrospective review study found the most common complication as isolated
postoperative dysphagia that was observed in 9.5% of the patients. Other complications
in decreasing frequency included; post op hematoma (5.6%), symptomatic recurrent
laryngeal nerve palsy (3.1%), dural tear (0.5%), esophageal injury (0.3%), worsening
myelopathy (0.2%), Horner’s syndrome and superficial wound infection (0.1%). On the
other hand, Romano et al. 55, using ICD9 codes to evaluate elective cervical discectomy
for DDD reported a 6.7% overall complication rate and 0.13% mortality, 1.8% infection,
0.09% recurrent laryngeal nerve palsy, 0.03% CSF leak and < 0.2% central nervous
system complication.
62
UNIVERSITY OF NAIROBI
Our study had a higher complication rate (20%) with a mortality of 5%. This can be
attributed to the small number of patients as compared to the much larger population of
the other two studies. Also, the study was prospective whereas Fouyas IP et al.
29
and
Romano et al. 55 studies were retrospective studies which have been noted to significantly
underestimate the overall incidences of complications when used in spine surgery (Lied
et al. 65).
5.2 Conclusions
The study concludes that degenerative cervical spine disorders are common in males than
females. In addition, the most common associated factor is previous trauma to the neck
and manual labour. The disorder’s common presenting symptom as well as indication for
surgery was radiculopathy. The single most common affected disc was C5/ C6.
The study further concludes that the most common operative approach was anterior, with
the commonest being ACDF with cage and plate.
Also, it concludes that surgery significantly led to improvement of symptoms three
months post operatively.
5.3 Limitations
The high cost of MRI scans limited the study to patients who could afford it.
The study could not conduct some procedures like AIDA and use of adynamic screws
because of the high cost of the implants.
63
UNIVERSITY OF NAIROBI
The types of implants used included titanium cages, screws and plates. The results are
therefore limited to the available implants and do not reflect the outcomes of the missing
implants.
The study did not use radiologic measurements including canal diameter and cobs angle
in the evaluation of the outcome.
64
UNIVERSITY OF NAIROBI
5.4 Recommendations
The general public should be educated on degenerative cervical spine disorders especially
the high risk groups including manual labourers, farmers and smokers. This is via audio
visual education as regards the symptoms and risk factors and therefore identify early the
population that require urgent intervention thereby minimize subsequent disability.
Companies/ employers whose employees engage in manual labour should offer
education, provide hospital insurance cover and develop good workman compensation
policy to their employees at risk of CDDD.
There is need for hospital insurance providers e.g. The National Hospital Insurance Fund
(NHIF) to provide cover that will cater for the acquisition of implants needed for surgical
management of CDDD.
MTRH, being the second largest referral hospital in Kenya should develop a policy that
will ensure the availability and provision of implants needed for management of CDDD
at an affordable cost.
Continued training of more neurosurgeons/ spine surgeons that will allow the provision
of services and cater for the high number of patients with degenerative disc disease.
There is need to conduct further studies with long term follow up to assess the long term
effects of the procedures including adjacent level disease. Further studies are also
recommended that will address radiologic measures like canal diameter and Cobb’s angle
to assess outcome relative to the measurements.
65
UNIVERSITY OF NAIROBI
REFERENCES
1. Andrew G. Todd. Cervical spine: degenerative conditions. Curr Rev Musculoskelet
Med. 2011 December; 4(4): 168–174.
2. Lawrence JS. Disc degeneration: its frequency in relationship to symptoms. Ann
Rheum Dis. 1969; 28:121–137. doi: 10.1136/ard.28.2.121.
3. Deepthi Gorapalli. Evaluation of a pGLcNAc-derived Material as an Activator of
Intervertebral Disc Tissue Repair. Unpublished MSc Thesis. University of Toronto.
2008.
4. Tamás Fülöp Fekete AND François Porchet. Overview of disc arthroplasty—past,
present and future. Acta Neurochir (2010) 152:393–404.
5. Fineberg S J, Oglesby M , Patel A A, et al. Outcomes of cervical spine surgery in
teaching and nonteaching hospitals.Spine. June 2013;38: 1089-1096.
6. White AA, III, Panjabi MM. Biomechanical considerations in the surgical
management of cervical spondylotic myelopathy. Spine (Phila Pa 1976) 1988;
13:856-860.
7. Vincenzo D, Alberto D M. Cervical Spine Surgery. A Historical Perspective. Clin
Orthop Relat Res (2011) 469:639–648 DOI 10.1007/s11999-010-1752-3.
8. De Kleuver M, Oner FC, Jacobs W. Total disc replacement for chronic low back
pain: background and a systematic review of the literature. Eur Spine J 2003;
12:108-116.
9. Jayme Hiratzka, Alex Ching, Robert Hart. Degenerative Cervical Kyphosis:
Anatomy, Biomechanics, and Etiology. Department of Orthopaedics and
Rehabilitation, Oregon Health and Science University, Portland, OR. Seminars in
Spine Surgery, September 2011.Volume 23, Issue 3 , Pages 170-172.
10. Kenya Demographic and Health Survey (KDHS) 2014. Kenya Bureau of Statistics
11. Gore DR, Sepic SB, Gardner GM. Roentgengraphic findings of the cervical spine in
asymptomatic people. Spine. 1986;11:521–524.
12. Ferdinandov, D., Tsekov, I., Bussarsky, V., Kalvatchev, Z. Biotechnologies in the
treatment of degenerative disc disease of the cervical spine. Biotechnology &
Biotechnological Equipment, 2012. Vol 26 (4): 3132-3137.
66
UNIVERSITY OF NAIROBI
13. Kellgren JH, Lawrence JS. Osteo-arthrosis and disk degeneration in an urban
population. Ann Rheum Dis. Dec 1958;17(4):388–397.
14. Lees F, Turner JW. Natural History and Prognosis of Cervical Spondylosis. Br Med
J. Dec 28 1963;2(5373):1607–1610.
15. Matsumoto M, Fujimura Y, Suzuki N, et al. MRI of cervical intervertebral discs in
asymptomatic subjects. J Bone Joint Surg Br. 1998;80:19–24.
16. Degefe A.B, Bernhard J. S, Zenebe G. Cervical spondylosis: a literature review
with attention to the African population Arch Med Sci 2007; 3, 4: 315-322
17. Kyung-Jin Song, Byung-Wan Choi, Sul-Jun Kim, Gyu-Hyung Kim, Young-Shin
Kim, and Ji-Hun Song. The Relationship between Spinal Stenosis and Neurological
Outcome in Traumatic Cervical Spine Injury: An Analysis using Pavlov's Ratio,
Spinal Cord Area, and Spinal Canal Area. Clin Orthop Surg. 2009 March; 1(1): 11–
18.
18. Abbed K M, Coumans J V. Cervical radiculopathy: pathophysiology, presentation,
and clinical evaluation. Neurosurgery 2007; 60:S28-S34.
19. Bjarne Lied M.D. Complications and clinical outcomes after surgery for
symptomatic subaxial cervical degenerative disease. Faculty of Medicine,
University of Oslo:Akademika publishing. No. 1432. 2012:6-30.
20. Ferguson R J, Caplan L R. Cervical spondylitic myelopathy. Neurol Clin
1985;3:373-382.
21. Kirkaldy-Willis WH. The relationship of structural pathology to the nerve root.
Spine 1984; 9:49.
22. Gore, D.R. et al, "Neck pain: A long-term follow-up of 250 patients", Spine, Vol.
12, No. 1, 1987
23. Robinson, R.A., et al, "Cervical spondylotic myelopathy: Etiology and treatment
concepts", Spine, Vol. 2, No. 2, 1977.
24. Williams K. Lower back pain and disorders of intervertebral discs. In: Canale ST
(ed). Campbell’s Operative Orthopaedics. Philadelphia : Mosby; 2003:1955-2028.
25. Lestini, W.F., and Wiesel, S.W., "The pathogenesis of cervical spondylosis", Clin
Orth Rel Res, 239:69-93, 1989.
67
UNIVERSITY OF NAIROBI
26. Fehlings MG, SKAF G. A review of the pathophysiology of cervical spondylotic
myelopathy with insights for potential novel mechanisms drawn from traumatic
spinal cord injury. Spine (Phila Pa 1976) 1998; 23:2730-2737.
27. Jäger HJ, Gordon-Harris L, Mehring UM, Goetz GF, Mathias KD. Degenerative
change in the cervical spine and load-carrying on the head. Skeletal Radiology
1997; 26: 475-81.
28. Taitz C. Osteophytosis of the cervical spines in South African blacks and whites.
Clin Anat 1999; 12: 103-9.
29. Fouyas IP, Statham PFX, Sandercock PAG. Cochrane review on the role of surgery
in cervical spondylotic radiculomyelopathy. Spine. 2002;15:736–747
30. Söderlund A, Lindberg P. Coping as a mediating factor between self-efficacy and
disability in Whiplash Associated Disorders (WAD) J Whiplash Rel Disord.
2002;15:25–37.
31. Fisher, D.K., Simpson, R.K., and Baskin, D.S., "Spinal spondylosis and disc
disease", in Evans R.W., Baskin, D.S., and Yatsu, F.M., Prognosis of Neurological
Disorders, Oxford University Press, New York, 1992.
32. Schaller B, Kruschat T, Schmidt H, Brück W, Buchfelder M, Ludwig HC.
Intradural, extramedullary spinal sarcoidosis: report of rare case and review of the
literature. Spine J 2006; 6: 204-10.
33. Anneli Peolsson,Birgitta Öberg, Johanna Wibault, Åsa Dedering, Peter Zsigmond,
Lars Bernfort, Ann-Sofi Kammerlind, Liselott CG Persson, and Håkan
Löfgren.Outcome of physiotherapy after surgery for cervical disc disease: a
prospective randomised multi-centre trial .BMC Musculoskelet Disord. 2014; 15:
34
34. Marjorie CW, Leighton C, Dennis JM, William K, Richard AD. Complications and
Mortality Associated With Cervical Spine Surgery for Degenerative Disease in the
United States. Spine 2007;32(3):342-347
35. Knaub M, Herkowitz HN. Anterior approach for Cervical Myelopathy. In: Simeone
FA, Rothman RH. The Spine. Philadelphia: WB Saunders; 2006:847-61.
36. Hacker RJ, Cauthen JC, Gilbert TJ, Griffith SL. A prospective randomized
multicenter clinical evaluation of an anterior cervical fusion cage. Spine.
2000;15:2646–2654.
68
UNIVERSITY OF NAIROBI
37. Peolsson A, Peolsson M. Predictive factors for long-term outcome of anterior
cervical decompression and fusion: a multivariate data analysis. Eur Spine J.
2008;15:406–414
38. Smith GW, Robinson RA. The treatment of certain cervical spine disorders by
anterior removal of intervertebral disc and interbody fusion. J Bone and Joint Surg
(Am) 1958;40:607-24.
39. John M. Rhee and Sushil Basra. Posterior Surgery for cervical myelopathy:
Laminectomy. Asian Spine J. 2008;2(2)2:114-126.
40. Smith GW, Robinson RA. The treatment of certain cervical spine disorders by
anterior removal of intervertebral disc and interbody fusion. J Bone and Joint Surg
(Am) 1958;40:607-24.
41. Cherubino P, Benazzo F, Borromeo U, Perle S. Degenerative arthritis of the
adjacent spinal joints following anterior cervical spinal fusion: clinicoradiologic and
statistical correlations. Ital J Orthop Traumatol. Dec 1990;16(4):533–543.
42. Smucker JD, Sasso RC. Cervical Disc Replacement: The State of the Data.
Seminars in Spine Surgery. 2006;18(2):53–60.
43. Phillips FM, Garfin SR. Cervical disc replacement. Spine (Phila Pa 1976). Sep 1
2005;30(17 Suppl):S27–33.
44. Traynelis VC. The Prestige cervical disc replacement. Spine J. Nov-Dec 2004;4(6
Suppl):310S-314S.
45. Mummaneni PV, Robinson JC, Haid RW, Jr. Cervical arthroplasty with the
PRESTIGE LP cervical disc. Neurosurgery. Apr 2007;60(4 Suppl 2):310–314;
discussion 314–315.
46. Hermansen A, Hedlund R, Vavruch L, Peolsson A. A comparison between the
carbon fiber cage and the Cloward procedure in cervical spine surgery: a 10–13
year follow-up of a prospective randomized study. Spine. 2011;15:919–925.
47. Peolsson A, Vavruch L, Hedlund R. Long-term randomised comparison between a
carbon fibre cage and the cloward procedure in the cervical spine. Eur Spine J.
2007;15:173–178.
69
UNIVERSITY OF NAIROBI
48. Peolsson A, Kjellman G. Neck Muscle endurance in non-specific patients with neck
pain and in patients after anterior cervical decompression and fusion. J
Manipulative Physiol Ther. 2007;15:343–350. doi: 10.1016/j.jmpt.2007.04.008.
49. Klein GR, Vaccaro AR, Albert TJ. Health outcome assessment before and after
anterior cervical discectomy and fusion for radiculopathy. A prospective analysis.
Spine 2000;25:801-3.
50. Loembe PM, Ndouongo PK, Ompounga LM, et al. Cervical spondylotic
myelopathy with functional disability. Long term results concerning 18 patients
operated on by anterior approach in Gabon. Af Jnl Neurological Sciences 2004; 23:
21-26.
51. Yonenobou K, Hosono H, Iwasaki M, et al. Laminoplasty versus subtotal
corpectomy: A comparative study of results in multi-segmental cervical spondylotic
myelopathy. Spine 1992;17:1281-4.
52. Sampath P, Bendebba M, Davis J, Ducker T. Outcome of patients treated for
cervical myelopathy. Spine 2000;25(6):670-6.
53. Matz PG, Ryken TC, Groff MW, Vresilovic EJ, Anderson PA, Heary RF, Holly
LT, Kaiser MG, Mummaneni PV, Choudhri TF, Resnick DK; Joint Section on
Disorders of the Spine and Peripheral Nerves of the American Association of
Neurological Surgeons and Congress of Neurological Surgeons: Techniques for
anterior cervical decompression for radiculopathy. J Neurosurg Spine 11: 183–197,
2009
54. Steinmetz MP, Kager CD, Benzel EC. Ventral correction of postsurgical cervical
kyphosis. J Neurosurg.2003;98(Suppl 1):1–7
55. Romano PS, Campa DR, Rainwater JA. Elective cervical discectomy in California:
postoperative in-hospital complications and their risk factors. Spine 1997;22:267792
56. Cartledge P, Harding R, Sebuyira LM, Higginson IJ. Prevalence, severity, duration,
and measurement of pain in sub-Saharan Africa. Pall Med 2004, 18:737–741.
57. Harding R, Powell RA, Kiyange F, Downing J, Mwangi-Powell F. Provision of
pain- and symptom-relieving drugs for HIV/AIDS in sub-Saharan Africa.J Pain
Symptom Manage 2010, 40:405–415
70
UNIVERSITY OF NAIROBI
58. Grant E, Murray SA, Grant A, Brown J: A good death in rural Kenya? Listening to
Meru patients and their families talk about care needs at the end of life. J Palliat
Care 2003, 19:159 – 167.
59. American Association of Neuroscience Nurses. Cervical Spine Surgery: A Guide to
Preoperative and Postoperative Patient Care. AANN Reference Series for Clinical
Practice, 2007: 4-40.
60. George P Malcolm. Surgical disorders of the cervical spine: presentation and
management of common disorders. J Neurol Neurosurg Psychiatry 2002;73.
61. Fehlings MG, Arvin B. Surgical management of cervical degenerative disease: the
evidence related to indications, impact, and outcome. J Neurosurg Spine. 2009
Aug;11(2):97-100
62. Erin McFadden, Sarah Jane Taleski, Alan Bocking, Rachel F. Spitzer, Hillary
Mabeya. Retrospective Review of Predisposing Factors and Surgical Outcomes in
Obstetric Fistula Patients at a Single Teaching Hospital in Western Kenya. J Obstet
Gynaecol Can 2011;33(1):30–35.
63. Bärlocher CB, Barth A, Krauss JK, Binggeli R, Seiler RW. Comparative evaluation
of microdiscectomy only, autograft fusion, polymethylmethacrylate interposition,
and threaded titanium cage fusion for treatment of single-level cervical disc disease:
a prospective randomized study in 125 patients Neurosurg Focus 2002;12:1-5.
64. Ioannis P Fouyas, Peter A G Sandercock, Patrick F X Statham, Ioannis Nikolaidis.
How beneficial is surgery for cervical radiculopathy and myelopathy? BMJ
2010;341.
65. Lied et al.: Anterior cervical discectomy with fusion in patients with cervical disc
degeneration: a prospective outcome study of 258 patients (181 fused with
autologous bone graft and fused with a PEEK cage. BMC Surgery 2010 10:10.
66. Baron EM, Soliman AM, Gaughan JP, et al. Dysphagia, hoarseness, and unilateral
true vocal fold motion impairment following anterior cervical diskectomy and
fusion. Ann Otol Rhinol Laryngol 2003;112:921-6
67. U.-D. Reips and F. Funke (2008) "Interval level measurement with visual analogue
scales in Internet-based research: VAS Generator
71
UNIVERSITY OF NAIROBI
68. Wilson JL, Hareendran A, Hendry A, et al. (2005). "Reliability of the Modified
Rankin Scale Across Multiple Raters: Benefits of a Structured Interview.". Stroke
36 (4): 777–781.
72
UNIVERSITY OF NAIROBI
APPENDICES
APPENDIX I: CONSENT FORM FROM THE PATIENT
I am a postgraduate resident in the division of Neurosurgery, Department of Surgery at
the University of Nairobi. I am carrying out a study on patterns and clinical outcomes of
surgically treated cervical disc disease at the Moi Teaching and Referral Hospital
(MTRH) Eldoret.
Purpose and procedure of study.
Degenerative disc disease is one of the most frequent spinal disorders and is a recognized
cause of morbidity. Surgery is a recognized treatment modality and there are various
surgical procedures to that effect. However, it comes with its complications. The purpose
therefore of this study is to investigate the patterns and clinical outcomes of surgically
treated cervical spine disc disease at MTRH. The outcome of this study will act as a good
reference point of patterns and clinical outcomes encountered in the surgical management
of these diseases and will form a baseline for improvement of outcomes. Data that will be
used in the research will be obtained from patients as well as the MRI scan.
Complications and outcomes will be assessed post operatively using a questionnaire and
a clinical examination form.
Risks and Benefits.
This is to assure you that there is no harm or risk to you for participating in this study. No
additional tests will be requested other than the routine for management of your
condition. There will be no extra cost to you for participating in the study.
Voluntary participation.
Participation in this study is voluntary and you will not be denied medical care in case
you refuse to participate. You may withdraw from participating in the study at any time
with no consequence whatsoever.
Confidentiality
All information will be treated with confidentiality and all information collected will be
destroyed at the end of the study. No records of names of the patients/ relatives will be
kept in the data collection. I, the undersigned have been explained to, understand the
above, and voluntarily accept to participate in the study.
Signature/ thumb print …………………………………………………………………….
73
UNIVERSITY OF NAIROBI
Telephone number ………………………………………..……………..............………..
KIAMBATISHO I: FOMU YA IDHINI KUTOKA KWA MGONJWA
Mimi ni mwanafunzi wa uzamili katika mgawanyo wa idara ya upasuaji katika chuo
kikuu cha Nairobi. Ninafanya utafiti kuhusu matokeo na madhara kufuatia upasuaji wa
sehemu ya juu ya uti wa mgongo.
Kusudi na utaratibu wa utafiti.
Sehemu ya juu ya uti wa mgongo ni muhimu katika.sehemu hii huadhiriwa ma magonjwa
kadhaa ambayo humwezesha mtu kupata hisia tofauti mojawapo uchungu na kutoweza
kufanya kazi kikamilifu.Madhumuni ya nakala hii ni kutathmini matokeo ya upasuaji
unaoniuwa kutibu magonjwa haya. Habari kutoka utafiti huu zitatumika kunuia sera
ambazo zitawezesha kuhudumia kikamilifu wale ambao wanaadhirika bila madhara
yoyote.data zitakazotumika katika utafiti huu zitapatikana kutoka kwa mgonjwa
mwenyewe pamoja na utafiti wa MRI. Habari kuhusu matokeo ya upasuaji yatapatikana
kwa kujaza dodoso iliyochapishwa. utafiti huu utafanywa kwa muda wa miezi sita.
Hatari na faida
Hii ni kuwahakikishia kwamba hakuna madhara au hatari kwa mgonjwa kwa ajili ya
kushiriki katika utafiti huu. Hakuna vipimo vya ziada vitakavyo takikana ila tu yale
ambayo yanahitajika kwa minajili ya matibabu. Hakutakuwa na gharama ya ziada kwa
kushiriki katika utafiti huu.
Hiari ushiriki.
Kushiriki katika utafiti huu ni hiari. Ni haki yako kukataa kushiriki katika utafiti huu au
kujiondoa kwa wakati wowote ule utakapojihisi.
Usiri
Taarifa zote zitashughulikiwa kwa siri. Hakuna kumbukumbu ya majina ya mgonjwa au
jamaa zitakazowekwa katika ukusanyaji wa data.
Nimeelewa maelezo yote kuhusu utafiti huu na kwa hiari nakubali kushiriki.
Sahihi/ alama ya kidole gumba……………………………………………..
Nambari ya simu………………………………………………
74
UNIVERSITY OF NAIROBI
APPENDIX II
DATA COLLECTION WORKSHEET
BIODATA;
Patient number
Study number
Age……………………………….
Sex …………………………...
Section A: Symptoms and Surgery Procedures
Symptoms
Duration of symptoms
Symptoms
<6 months
Radiculopathy
Myelopathy
Paraesthesia
Neck pain
Upper limb weakness
Lower limb weakness
Sphincter disturbance
Family history of cervical degenerative disc disease (a) Yes (b) No
If Yes, who (a) Nuclear family (b) Extended family
History of previous neck trauma (a) Yes (b) No
Do you take alcohol (a) Yes (b) No
75
> 6 months
UNIVERSITY OF NAIROBI
Do you smoke (a) Yes (b) No
Occupation (a) Clerical (b) Manual labour (c) House wife (d) Sports person (e) Driver
(f) Doctor/Nurse
(g) Others, please specify................................................................................
Does the patient present with any of the following co-morbidities?
1. Diabetes (a) Yes (b) No
2. Rheumatoid Arthritis (a) Yes (b) No
3. Osteoarthritis (a) Yes (b) No
4. Renal insufficiency (a) Yes (b) No
Imaging findings/ level of disease affected (tick where appropriate)
C2/C3
C3/C4
C4/C5
C5/C6
C6/C7
C7/T1
Indications for surgery (tick where appropriate)
Severe pain/ radiculopathy
Severe weakness
myelopathy
Sphincter anomaly
Failed conservative management
Operative procedure done (tick where appropriate);
Procedure
Level
done
e.g.
C3/C4
Cage screws
dynamic
ACDF
Microdiscect Anterior
omy
Posterior
Cervical laminectomy
Cervical laminoplasty
76
Implant used
Plate
Adynamic
Autologous AIDA
bone graft
UNIVERSITY OF NAIROBI
POST OPERATIVE COMPLICATIONS; (tick appropriately)
Vascular injury
Post op haematoma
Dysphagia
Recurrent laryngeal nerve
palsy
Neck pain
others
CLINICAL OUTCOMES;
Outcome measure
Preoperative
12 weeks post operative
Visual Analog Scale
( VAS, 0- 10)
MRS
MODIFIED RANKIN SCALE (MRS)
Patient Number……………………..............Date: ………....………………………..
Score Description
0
No symptoms at all.
1
Significant disability despite symptoms; able to carry out all usual duties and activities.
2
Slight disability; unable to carry out all previous activities, but able to look after own
affairs without assistance.
3
Moderate disability; requiring some help, but able to walk without assistance.
4
Moderately severe disability; unable to walk without assistance and unable to attend to
own bodily needs without assistance.
5
Severe disability; bedridden, incontinent and requiring constant nursing care and attention.
6
Dead.
77
UNIVERSITY OF NAIROBI
VISUAL ANALOQUE SCORE FOR ASSESSING PAIN
78
UNIVERSITY OF NAIROBI
APPENDIX III: BUDGET ESTIMATES AND STUDY TIME FRAME
BUDGET ESTIMATES
ITEM
COST (KShs)
Stationery
20,000
Statistician
20,000
Printing and Binding
5000
Contingencies
20,000
Airtime
3000
Transport ( average 1,500 x 40 subjects x 2
trips for follow up)= 120,000
120,000
TOTAL
188,000
STUDY TIME FRAME
Proposal writing and submission for ethical approval
April - July 2014
Data Collection and Analysis
October 2014 to May, 2015
Dissertation writing
June 2015
Presentation and submission of dissertation
July 2015
79