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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. 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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