Download appendix – iii

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
SYNOPSIS
OF
DISSERTATION
“SURGICAL MANAGEMENT OF FRACTURE BOTH
BONES FOREARM IN ADULTS USING LOCKING
COMPRESSION PLATE (LCP)”
Submitted by
Dr. SIDDIQUI MOHAMMAD SHAD
M.B.B.S.,
POST GRADUATE STUDENT IN
ORTHOPAEDICS (M.S.)
DEPARTMENT OF ORTHOPAEDICS
ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES,
B.G.NAGARA-571448
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
Dr. SIDDIQUI MOHAMMAD SHAD
P.G. IN ORTHOPAEDICS
ADICHUNCHANAGIRI INSTITUTE OF
MEDICAL SCIENCES, B.G. NAGARA,
MANDYA DISTRICT -571448
1
NAME OF THE CANDIDATE
AND ADDRESS
(in block letters)
2.
NAME OF THE INSTITUTION
3.
COURSE OF STUDY AND SUBJECT
M.S.IN ORTHOPAEDICS
4.
DATE OF ADMISSION TO COURSE
1st JUNE 2012
5.
TITLE OF THE TOPIC
6.
BRIEF RESUME OF INTENDED WORK
7
ADICHUNCHANAGIRI INSTITUTE OF
MEDICAL SCIENCES, B.G.NAGARA.
“SURGICAL MANAGEMENT OF
FRACTURE BOTH BONES FOREARM
IN ADULTS USING LOCKING
COMPRESSION PLATE (LCP)”
APPENDIX-I
6.1 NEED FOR THE STUDY
APPENDIX-IA
6.2 REVIEW OF LITERATURE
APPENDIX-IB
6.3 OBJECTIVES OF THE STUDY
APPENDIX-IC
MATERIALS AND METHODS
APPENDIX-II
7.1 SOURCE OF DATA
APPENDIX-IIA
7.2 METHOD OF COLLECTION OF
DATA : (INCLUDING SAMPLING
PROCEDURE IF ANY)
APPENDIX-IIB
7.3 DOES THE STUDY REQUIRE ANY
INVESTIGATION OR INTERVENTIONS
TO BE CONDUCTED ON PATIENTS OR
OTHER ANIMALS, IF SO PLEASE
DESCRIBE BRIEFLY.
YES
APPENDIX-IIC
7.4 HAS ETHICAL CLEARENCE BEEN
OBTAINED FROM YOUR INSTITUTION
IN CASE OF 7.3
YES
APPENDIX-IID
8.
LIST OF REFERENCES
APPENDIX – III
9.
SIGNATURE OF THE CANDIDATE
1
10.
REMARKS OF THE GUIDE
11
NAME AND DESIGNATION
(in Block Letters)
11.1 GUIDE
There are many methods for treatment
for fracture both bone forearm. But
none have proved to give satisfactory
treatment. LCP with ideal treatment for
osteoporotic comminuted fracture for
treatment for osteoporotic segmental
fracture.
Dr. GUNNAIAH. K.G. MBBS, D-ORTHO, MS ORTHO
Professor and Head of Department,
Department of Orthopaedics,
AIMS, B.G. Nagara-571448
11.2 SIGNATURE OF THE GUIDE
11.3 CO-GUIDE (IF ANY)
-
11.4 SIGNATURE
11.5 HEAD OF DEPARTMENT
Dr. GUNNAIAH. K.G. MBBS, D-ORTHO, MS ORTHO
Professor and Head of Department,
Department of Orthopaedics,
AIMS, B.G. Nagara-571448
11.6 SIGNATURE
12
12.1 REMARKS OF THE CHAIRMAN
AND PRINCIPAL
The facilities required for the investigation will be
made available by the college
Dr. M.G SHIVARAMU M.B.B.S., MD
PRINCIPAL,
AIMS, B.G. NAGARA.
12.2 SIGNATURE
2
APPENDIX-I
6.BRIEF RESUME OF THE INTENDED WORK:
APPENDIX –I A
6.1 NEED FOR THE STUDY:
The forearm has a complex architecture consisting of 2 mobile relatively parallel bones
that provide a stable link between elbow and wrist and serve as the origin of several muscles
inserting on the hand. As a result, fracture of both bones forearm present unique problems not
encountered with fractures of the shaft of other long bones. Restoration of forearm rotation,
elbow and wrist motion and grip strength has been shown to be facilitated by anatomic
reduction and internal fixation of these fractures.1
The forearm rotation is the most important contribution to the rotational mobility of the
upper limb. The two bone unit with its proximal and distal radio-ulnar joints, and its rotational
axis connecting the centre of the two, have been viewed as a single bicondylar joint. When
combined with rotational motion of the shoulder, forearm rotation permits the hand to be
positioned through an entire 3600 arc of motion. with the shoulder fully abducted, nearly all of
the rotational motion of the upper limboccurs through the forearm . Activities such as accepting
the objects in the palm of the hand require nearly full forearm supination. While many other
functional tasks require some degree of pronation.2
The radial bow should be maintained for the good functional outcome. It is important to
regain the length of the bones, good apposition and alignment without any malrotation. In the
normal forearm, the maximal radial bow is reported to be about 15mm and located at 60% of
radial length from the distal end. For the rotation of the forearm to be 80% of the opposite side,
the normal radial bow should not differ more than 1.5mm and its location should not differ by
more than 9% from that of normal arm.3
3
Stabilization with internal plate fixation following fracture of both bones forearm
restores nearly normal anatomy and motion. However, a moderate reduction in the strength of
the wrist and forearm, grip should be expected.
The plates most widely used for the internal fixation of the forearm fractures are 3.5mm
locking compression plate (LCP). In the present study, Diaphyseal fractures of both bones
forearm are surgically treated with Locking Compression Plate (LCP)” in Adichunchanagiri
Institute of medical sciences, B.G.Nagara. The forearm rotation and wrist and elbow
movements, time taken for union, rate of union and the complications are studied.
APPENDIX –I B
6.2 REVIEW OF LITERATURE
Some form of external splintage was the only option for the management of fractures for
thousands of years. The Egyptians used palm bark and linen bandages 5000 years ago; Clay
and also lime mixed with egg- white were used. But the material most commonly used has
been wood.4
Wood is still widely used for splintage. eg Amerasinghe of Srilanka has published.
Good results from functional bracing using shaped bamboo for tibial fractures. 4
The first attempt at internal fixation took place around 1770 in Toulouse France where
2 surgeons Lapejode and Sicre, are recorded to have used brass wire for circlage of long bone
fractures.5 John Kearney Rogers used silver wire suture to stimulate healing non unions in
1820's.5
The term "Osteosynthesis" was coined by Albin Lambotte (1866-1955), a Belgian
surgeon regard universally as the "Father Of Modern Internal And External Fixation". He
4
devised numerous different plates and screws with surgical instruments for implantation in
fracture surgery.5
In 1937 J.H.Rush et al, developed Rush nails for monteggia fractures.6 Steinmann pins
were initially used by Lambrinudi and Dickson in1939.7 In late 1930's Campbell and Boyd
used autogenous tibial grafts fixed to the radius and ulna with both bone pegs screws for acute
fractures as well as non unions. Fatigue fractures developed before they re-vascularised and led
to failure in many cases.8
In 1945, Mervyn Evans described the method to determine the rotational alignment in
forearm fractures by the so called tuberosity view.9
In 1948, Eggers introduced slotted plate, also known as "contact splint". This plate was
much stronger than those used previously and it provided better fixation,10 because of this
plates gained favour again.
In 1957, the collision plate modified by Bagby and Janes was a self compressing plate.
It corresponds to an old carpenter's principle that" when a screw is eccentrically positioned
within conical recess and is driven home, the inclined surface of the screw is of the plate hole
and displacement perpendicular to the long axis of the screw is produced.11 "
Sage et al reported on 555 cases in 1957, had treated them with intra medullary nails.
The failure rate was 14%12.
Burwell and Charnley in 1964, treated forearm fractures in adults using plates. They
believed that plate fixation as the most satisfactory treatment for forearm fractures and can
achieve good functional results with avoidable complications.13
In 1965, Muller published a book " Manual of internal fixation ". AO formulated 4
treatment principles of fracture treatment. They were : anatomical reduction of the fracture
5
fragments, stable internal fixation , preservation of blood supply to the bone fragment, early
active pain free mobilization of the adjacent muscles and joints.14
In 1975, Augusto Sarmiento, studied early functional bracing of forearm fractures using
below elbow brace, which permitted flexion-extension of the wrist and elbow, while limitting
pronation-supination of the forearm during fracture's preoperative period. The results were
rewarding.15
In 2009, Jesse, B. Jupiter and Diego.L.Fernandez in their study " Reconstruction of post
traumatic disorder of the forearm ” stressed on the forearm kinesiology. Forearm rotation is the
most important contribution to the rotational mobility of the upper limb. The two bone unit
with its proximal and distal radio ulnar joints and its rotational axis connecting the centres of
the two, have been viewed as single bicondylar joint. They studied the pathomechanics of the
forearm malunion and clinical correlation with forearm rotation. Deformities in the distal third
of forearm decrease pronation. Angulation upto 100 in the middle third of radius/ ulna, or both,
donot limit rotation, but deformities of 200 restrict forearm rotation by atleast 30% and
angulations of >200 resulting in even in greater restrictions. Rotational deformities may also
displace and decrease pronation- supination arc of motion.2
Treatment of radius or ulna nonunion requires both osteogenic environment and
mechanical stability. Three radial and six ulnar diaphyseal nonunions treated with 3.5 mm
locking compression plate (LCP) fixation were reported by Ling HT et al. To assess the
effectiveness of 3.5 mm LCP in treating diaphyseal nonunion of the forearm bones,
prospectively reviewed nine patients with the mean age of 33 years with diaphyseal nonunion
of the radius or ulna. All patients were treated with 3.5 mm LCP. Bone grafting was only
performed for atrophic nonunion. Surgical and functional outcome were evaluated. There were
three atrophic nonunion of the radius, four atrophic nonunion of the ulna and two hypertrophic
6
nonunion of the ulna. All nonunion united successfully with satisfactory functional outcome.
3.5 mm LCP is effective in the treatment of nonunion of ulna or radius.16
Denju Osada et al investigated internal fixation and early mobilization of dorsally
displaced, unstable fractures of the distal radius using a volar locking plate system without
bone grafting in a prospective series of 49 fractures in 49 consecutive patients. They concluded
that the volar locking plate fixation without bone grafting and early mobilization is a safe and
effective treatment for dorsally displaced, unstable fractures of the distal radius.17
Saikia et al stated that the locking compression plate (LCP) with combination holes is a
newer device in fracture fixation. They undertook a study comparing the Locking Compression
Plate (LCP)” with limited contact dynamic compression plate (LC-DCP) in the treatment of
diaphyseal fractures of both bones of the forearm. This is a prospective comparative study, 36
patients (18 in each group) with fractures of both the forearm bones (72 fractures) were treated
with one of the two devices. Disabilities of the Arm, Shoulder and Hand (DASH) score for
patient related outcome at the latest follow up. LC plating is an effective treatment option for
fractures of both bones of forearm. This study concluded that no significant difference in two
groups with respect to the range of movements or grip strength.18
Leung et al evaluated the use of locking compression plates (LCPs) in diaphyseal
forearm fractures. They concluded that Locking Compression Plate (LCP)” is an effective
bridging device used for treating comminuted fractures, but for treating simple fractures its
superiority over conventional plating is yet to be proven.19
Snow et al study determined if locking compression plates (LCP) are mechanically
advantageous compared to low-contact dynamic compression plates (DCP) when used as a
bridging plate in a synthetic model of osteoporotic bone. Their study concluded that in a
7
synthetic model, the Locking Compression Plate (LCP) was mechanically superior to the DCP
when used as a bridging plate and tested in axial compression.20
APPENDIX –IC
6.3 AIMS AND OBJECTIVES OF STUDY
1) To study the functional outcome of the plating of diaphyseal fracture of the both bone
forearm with LCP in adults.
2) To study the biomechanics of forearm fracture and forearm kinesiology and its
relevance in better functional outcome of treating forearm fracture.
3) To study age and sex distribution of the patients with fracture of both bone forearm in
adults.
4) To study the advantages and complications of LCP plating of fracture of both bone
forearm.
8
APPENDIX-II
7.0 MATERIALS AND METHODS
APPENDIX-II A
7.1 SOURCE OF DATA
Patients with both bone fracture forearm, who are admitted in Sri Adichunchanagiri
Institute of Medical Sciences, will be taken for study after obtaining their consent.
APPENDIX-II B
7.2 METHOD OF COLLECTION OF DATA
INCLUSION CRITERIA
1. The patient with closed diaphyseal fractures of both bones forearm
2. Comminuted fracture.
3. Osteoporotic fracture.
4. Segmental fracture.
5. Age above 18 years.
EXCLUSION CRITERIA
1. Patients medically unfit for surgery.
2. Open fractures.
3. Children below 18 yrs of age.
APPENDIX-II C
7.3 Does the study require any investigation or intervention to be conducted on the
patients or animals, if so please describe briefly
YES
1. X-ray of both bones forearm
a. Anteroposterior view
b. Lateral view
2. Routine investigation to evaluate fitness for surgery
9
APPENDIX-IID
PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL
SECTION A
Title of the study
“SURGICAL MANAGEMENT OF
FRACTURE BOTH BONES FOREARM IN
ADULTS USING LOCKING COMPRESSION
PLATE (LCP)”
b
Principle investigator
(Name and Designation)
Dr. SIDDIQUI MOHAMMAD SHAD
P.G. IN ORTHOPAEDICS
ADICHUNCHANAGIRI INSTITUTE OF
MEDICAL SCIENCES, B.G. NAGARA,
MANDYA DISTRICT -571448
c
Co-investigator
(Name and Designation)
d
Name of the Collaborating
Department/Institutions
NO
e
Whether permission has been obtained from
the heads of the collaborating departments &
Institution
NA
a
Dr. GUNNAIAH. K.G. MBBS, D-ORTHO, MS ORTHO
Professor and Head of Department,
Department of Orthopaedics,
AIMS, B.G. Nagara-571448
Section – B
Summary of the Project
Section – C
Objectives of the study
Section – D
Methodology
APPENDIX – I
APPENDIX – II
A Where the proposed study will be undertaken
S.A.H. & R.C., B.G.NAGARA
B Duration of the Project
36 MONTHS FROM JUNE 2012
C Nature of the subjects:
Does the study involve adult patients?
YES
Does the study involve Children?
NO
Does the study involve normal volunteers?
NO
Does the study involve Psychiatric patients?
NO
Does the study involve pregnant women?
NO
10
D If the study involves health volunteers
I. Will they be institute students?
NO
II. Will they be institute employees?
NO
III. Will they be Paid?
NO
IV. If they are to be paid, how much per
NO
session?
E Is the study a part of multi central trial?
NO
F If yes, who is the coordinator?
(Name and Designation)
NA
Has the trail been approved by the ethics
Committee of the other centers?
NA
If the study involves the use of drugs please
indicate whether.
NA
I. The drug is marketed in India for the
indication in which it will be used in the study.
NA
II. The drug is marketed in India but not for
the indication in which it will be used in the
study
NA
III. The drug is only used for experimental use
in humans.
NA
IV. Clearance of the drugs controller of India
has been obtained for:
NA
 Use of the drug in healthy volunteers
 Use of the drug in-patients for a new
indication.
NA
 Phase one and two clinical trials
 Experimental use in-patients and healthy
volunteers.
11
G How do you propose to obtain the drug to be
used in the study?
-
Gift from a drug company
-
Hospital supplies
-
Patients will be asked to purchase
-
Other sources (Explain)
NA
H Funding (If any) for the project please state
-
None
-
Amount
-
Source
-
To whom payable
NONE
Does any agency have a vested interest in the
I
NO
out come of the Project?
Will data relating to subjects /controls be stored
J
YES
in a computer?
Will the data analysis be done by
K
-
The researcher
YES
-
The funding agent
NO
L Will technical / nursing help be required form
NO
the staff of hospital.
If yes, will it interfere with their duties?
NO
Will you recruit other staff for the duration of
NO
the study?
If Yes give details of
I.
Designation
II.
Qualification
III.
Number
IV.
Duration of Employment
NA
12
M Will informed consent be taken? If yes
Will it be written informed consent:
Will it be oral consent?
YES, CONSENT WILL BE TAKEN FROM
THE PATIENT
Will it be taken from the subject themselves?
Will it be from the legal guardian? If no, give
reason:
N Describe design, Methodology and techniques
APPENDIX II
Ethical clearance has been accorded.
Chairman,
P.G Training Cum-Research Institute,
A.I.M.S., B.G.Nagara.
Date :
PS : NA – Not Applicable
13
APPENDIX-III
8. LIST OF REFERENCES
1. Kurt.P.Droll, PhilipPerna; Outcome following plate fixation of fracture of both bones of
forearm in adults. JBJS (Am) 2007; Vol 89-a; pp2619-24.
2. Jesse.B.Jupiter; Reconstruction of post traumatic disorders of the forearm. JBJS (Am);
Vol 91-A, Nov 2009. PP 2730-2737.
3. Ralph.Hertel ; Domique.A.Rothenfluh; Fractures of the shaft of the radius and ulna;
chapter 27 in Rockwood & Green fractures in adults by Robert.W.Bucholz,
James.D.Heckman, 2006; pp967-987.
4. Sevitt, Simon. Primary repair of fractures and compression fixation. Chap-10 in bone
repair and fracture healing in man. Churchill Livingstone, Edinburgh, 1981; pp145-156.
5. Colton C. History of Osteosynthesis. Chap-2 in AO/ ASIF Instruments and Implants,
2nd ed, Texhammer R, C.Colton, Berlin, Springer Verlag, 1994 ; pp3.
6. Rush LV, Rush HL. A reconstructive operation for comminuted fractures of upper third
of ulna. Am J surg 1937; 38:332.
7. Lambrunidi C. Intramedullary Kirshner Wires in the treatment of fractures proceedings
of Royal Society of Medicine 1939;33:153.
8. Knight RA, Purvis GD. Fracture of both bones of forearm in adults. JBJS 1949:31A;755-764.
9. Evans EM. Rotational deformity in the treatment of fracture of both bones of forearm.
JBJS 1945; 24: 373-379.
10. Eggers GWN. Internal Contact Splint. JBJS 1948 ;30A (1): 40-52.
11. Perrens M, Allgower M, Brunner H, Burch HB, Cordey J, Ganz R et al. The concept of
biological plating using the limited contact dynamic compression plate. Injury 1991;
22(1): 1-41.
12. Sage FP, Smith H. MedulalryFixation of forearm fractures. JBJS 1957; 39(A): 91-109.
14
13. Burwell HN, Arnold D. Charnley. Treatment of forearm fractures in adults with
particular reference to plate fixation. JBJS 1964; 46-B(3), 404-424.
14. Muller ME, Allgower M, Willenger H. Technique of internal fixation of fractures, 1st
ed New York, Springer Verlag 1965.
15. Sarmiento, Augusto, Jack S, Cooper and William F, Sinclair. Forearm fractures. JBJS
1975; 57-A (3): 297-304.
16. Ling HT, Kwan MK, Chua YP, Deepak AS, Ahmad TS. Locking compression plate:a
treatment option for diaphyseal nonunion of radius or ulna.Med J Malaysia, 2006Dec;
61 Suppl B: 8-12.
17. Denju O, Shuzo K, Masuzaki T, Kameda M, Tamai K. Prospective Study of Distal
Radius Fractures Treated With a Volar Locking Plate System. J Hand Surg 2008;
Vol.33, (5): 691-700.
18. Saikia KC, Bhuyan SK, Bhattacharya, Borgohain M, Jitesh P, Ahmed F. Internal
fixation of fractures of both bones forearm: Comparison of locked compression and
limited contact dynamic compression plate. Indian J Orthop. 2011 Sep-Oct; 45(5): 417–
421.
19. Leung F, Chow SP.Locking compression plate in the treatment of forearm fractures: a
prospective study.J of Orth Surg 2006; 14(3): 291-4.
20. Snow M, Thompson G, Turner PG. A mechanical comparison of the locking
compression plate (LCP) and the low contact-dynamic compression plate (DCP) in an
osteoporotic bone model. J Orthop Trauma 2008 Feb; 22(2): 121-5.
15