THROUGH PROPER CHANNEL

To,
The Registrar
MUHS, Nashik – 422004
Sub.: Submission of Title & Synopsis of Dissertation
Respected Sir/Madam,

I Dr. Shailesh Shevale, registered for M.S. Orthopaedics in the 2016 batch
under the guidance of Dr. Jayant D. Thipse, Professor, Department of
Orthopaedics, PADMASHREE DR.VITTHALRAO VIKHE PATIL
FOUNDATION’S MEDICAL COLLEGE & HOSPITAL, AHMEDNAGAR.

I am submitting herewith Title of Synopsis of Dissertation as mentioned

below & as suggested by my aforesaid Guide.

Title of Synopsis

“Study of Functional and Radiological Outcome of Anterior

Cervical Discectomy and Fusion by Smith Robinson
Approach”

Kindly accept and register my Title of Synopsis.

Dr. Shailesh S. Shevale

(Candidate Name & Signature)

Dr. Jayant D. Thipse. Dr. Jayant D. Thipse

(Guide Name & Signature) (HOD Name & Signature)

(Signature & Seal of Dean of College)

1
 Study of Functional and Radiological
Outcome of Anterior Cervical Discectomy
and Fusion by Smith Robinson Approach

Dr. Shailesh S. Shevale

Department of Orthopaedics,
PDVVPF’s Medical College & Hospital,
Ahmednagar.

2
 CONTENTS

1) APPLICATION FORM (APPENDIX 1)

2) RESEARCH PROPOSAL(APPENDIX 2)

3) INFORMED CONSENT(APPENDIX 3)
A.ENGLISH
B.MARATHI

4) UNDERTAKING BY THE INVESTIGATOR (APPENDIX 4)

5) CERTIFICATE FROM HEAD OF THE

DEPARTMENT(APPENDIX 5)

3
 Appendix: 1
VIKHE PATIL INSTITUTE OF MEDICAL
SCIENCES AHMEDNAGAR
INSTITUTIONAL ETHICS COMMITTEE
SR.NO Submission Approved Resubmission Not Approved

Date

Sr.no Title Particulars

1 Title of the research Study of Functional and
proposal Radiological Outcome of
Anterior Cervical Discectomy
and Fusion by Smith Robinson
Approach.
2 Name of the PG student Dr. Shailesh S. Shevale
with qualification and M.B.B.S.,
designation Resident in Orthopaedics.
3 Name of the PG Guide Dr. Jayant D. Thipse
with qualification and (M.B.B.S, D. Ortho, M.S. Ortho)
designation
Professor & HOD,
Dept Of Orthopaedics.
PDVVPF’s Medical College &
Hospital,ViladGhat,
Ahmednagar,Maharashtra414111
4 Source of the funding and PDVVPF’s Medical College &
financial allocation for the Hospital, Ahmednagar.
project/trial

4
5 Duration of the project From date of approval of
synopsis to December 31, 2018

6 Name of the Department of Orthopaedics,

institute/department where PDVVPF’s Medical college and
research is to be conducted Hospital,
Ahmednagar.
7 Is the research proposal Yes
approved by technical
committee
8 Is approval by other ethics No
committees required?
9 Will the research proposal No
be submitted to any
ministry screening
committee for international
collaboration?
10 List of the documents Application form
enclosed for ethical review Research proposal
Informed Consent
a. English
b. Marathi
Undertaking
Certificate by HOD

5
11 Research proposal: Study of Functional and
Relevant background Radiological Outcome of
information Anterior Cervical Discectomy
and Fusion by Smith Robinson
Approach (Detail in synopsis)

12 Research proposal: main Synopsis attached.

objective
13 Usefulness for the project Beneficial to community
attending our hospital.
14 Expected benefit to Early mobilization of the joint
volunteer/community thereby preventing complications
related to immobilization
15 Benefits to, if any -
16 Explain all anticipated Nil
risks(ADR, Injury,
discomfort) of the project
17 Efforts taken to minimize NA
the risks
18 Explain the plans to Records will be managed by
maintain confidentiality of MRD department. It will not be
records/data. disclosed to anyone except
patient.

19 Whether wage NA
compensation for the
research subjects be
provided

6
20 Research subject Attached
information form
21 Describe the informed Attached
consent process
22 Disclose conflicts of No
interests, if any
23 Specific ethical issues, as No
identified by the
investigating team

24 Signature of the PG
student with date

7
 Appendix: 2

Study of Functional and Radiological Outcome of Anterior

Cervical Discectomy and Fusion by Smith Robinson
Approach

Synopsis submitted to

Maharashtra University of Health Sciences, Nashik.

FOR THE DEGREE OF

M.S. ORTHOPAEDICS

8
 -DR. SHAILESH S. SHEVALE
M.B.B.S.

GUIDE:
DR. JAYANT D. THIPSE (D. Ortho, M.S. Ortho)

CO-GUIDE:
DR. NITIN A. BHALERAO (M.S. Ortho)

AT PADMASHREE DR. VITHALRAO VIKHE PATIL

FOUNDATION’S MEDICAL COLLEGE,
VILAD GHAT, AHMEDNAGAR.

9
SUBJECT KEYWORDS-
Anterior cervical fusion, Cervical compressive myelopathy, Cervical
PIVD.

STUDY TYPE-
A Prospective longitudinal clinical study

Period of study
Starts from date of approval of synopsis to December 31, 2018.

AIMS AND OBJECTIVES-

• To evaluate the functional and radiological outcomes of anterior
cervical fusion.
• To compare the results of this study with reported studies.
• To study the advantages and disadvantages of this technique.

10
Introduction
Anterior cervical discectomy and fusion procedures are one of the most
common procedures performed in spinal surgery.4 Since its original
description over 50 years ago, numerous studies have demonstrated the
effectiveness of ACDF; patients generally experience rapid recoveries,
and dramatic improvement in their quality of life. 8,9 A series of 66
patients who underwent 75 procedures is reported. The follow-up period
ranged from one to five years. Good to excellent results were obtained
with 91% of the operations for disc disease, and good results in all cases
of fracture-dislocation.6
Cervical myelopathy encompasses a range of symptoms and
examination findings including motor and sensory abnormalities related
to dysfunction of the cervical spinal cord. The pathophysiology of CSM
is now thought to be multifactorial with both static factors causing
stenosis and dynamic factors resulting in repetitive injury to the spinal
cord playing a role. Operative treatment remains the standard of care for
moderate to severe CSM and is most effective in preventing the
progression of disease. Anterior surgery is generally recommended for
patients with disease limited to a few segments and patients with a fixed
cervical kyphosis. An anterior procedure will allow direct
decompression of the spinal canal in addition to indirect decompression
by correction of the deformity. A posterior procedure in this setting has
the theoretical risk of leaving the spinal cord compressed anteriorly

11
against any spondylotic bars or disc bulges in the kyphotic segment of
the spine.5
In a study sixty cases of cervical trauma (fractures, subluxations,
ligamentous instability, or a combination of these problems) were
treated with plating. All patients obtained fusion, and stability was
achieved immediately after surgery without external stabilization. No
unusual surgical complications occurred.2
Anterior cervical discectomy and fusion (ACDF) is the current gold
standard for managing symptomatic anterior cervical degenerative disc
disease.7 Anterior nerve root decompression via anterior cervical
discectomy (ACD) with fusion for radiculopathy is associated with rapid
relief (3-4 months) of arm/neck pain, weakness, and/or sensory loss
compared with physical therapy (PT) or cervical collar immobilization.
Anterior cervical discectomy and ACD with fusion (ACDF) are
associated with longer term (12 months) improvement in certain motor
functions compared to PT. Other rapid gains observed after anterior
decompression (diminished pain, improved sensation, and improved
strength in certain muscle groups) are also maintained over the course of
12 months.3
There are 3 commonly used techniques for anterior cervical spine fusion.
Those of Robinson – Smith, Bailey and Badgley and Cloward. The
Robinson-Smith used tricortical iliac crest autograft, Bailey and Badgley
used slot or trough type graft and Cloward used circular dowel graft. The
Robinson-smith is found to be strongest in compressive loading.1
This study is intended to assess the functional and radiological outcome
of anterior cervical discectomy and fusion, its technical difficulties and
outcome.

12
Methodology

1. Plan of research
All cases requiring anterior cervical fusion will be included in the study.

2. Selection of Cases
a. Inclusion Criteria
All patients having the following and requiring surgical intervention will
be included in the study
1. Cervical spine trauma and resulting instability
2. Radiculopathy secondary to cervical disc prolapse
3. Cervical compressive myelopathy
b. Exclusion Criteria
Bleeding/coagulation disorders

3. Instruments Required
General orthopedic spine instruments

13
 Bipolar cautery
Anterior cervical plates and screw set
Skin hooks
Kochers clamp
Burr
Oscillating saw

4. Operative Technique
a. Anaesthesia
• General

b. Patient Positioning
• Pt. supine on operating table.
• Pt scrubbed, painted and draped from chin to chest.

c.Surgical Technique1
Place the patient supine on the operating table under general anesthesia
with the patients head slightly rotated to the side opposite the planned
approach.
Incision is taken along the anterior cervical skin crease along the medial
border of the sternocleidomastoid. After dividing the skin, sharp
dissection of the subcutaneous layer and the platysma is carried out by
lifting it in between two pairs of skin hooks.
Interval is developed medial to SCM and between carotid sheath and
omohyoid and pretracheal fascia is divided medial to the carotid sheath
and the longus colli muscles are visualized after blunt finger dissection.
A localization radiograph is obtained using a prebent needle to mark the
spinal level. A 11 no blade is used to remove anterior annulus at the

14
desired level cutting toward midline from the uncovertebral joint. Disc
forceps are used to remove the disc from that space.
The adjacent endplates are prepared using a burr so that all cartilage is
removed, subchondral bone is preserved and endplates are parallel to
each other.
Measurement of the anteroposterior dimension and the cephalocaudal
dimension is done between the endplates under traction.
A tricortical iliac graft is obtained of the appropriate size using a
oscillating saw and the bone graft is fashioned to appropriate depth.
The graft is held with Kochers clamps and positioned with the
cancellous surface directed posteriorly with traction applied.
Anterior cervical instrumentation is applied and fixed with appropriate
sized screws with traction released. Intraoperative radiographs are
obtained to verify graft and hardware position and wound is closed and
dressing is done and cervical collar is placed before extubation.

5. Evaluation
a. Clinical Parameter- Pre-operative
1. Gait
2. Tingling numbness
3. Sensory deficit
4. Muscle power
5. Reflexes
6. Bladder/bowel involvement

b. Radiological Parameter- Pre-operative

15
MRI evidence of myelopathy/pivd/myelomalacia/# leading to instability.

c. Clinical Parameter- Intra-operative

d. Clinical Parameter- Post-operative

Follow up will be done on OPD basis every monthly for six months
postoperatively with clinical and radiological evaluation, based on:
1. Gait
2. Tingling numbess
3. Sensory deficit
4. Muscle power
5. Reflexes
6. Bladder/bowel involvement
e. Radiological Parameter- Post-operative
Xray to evaluate position of plate and screws and graft size.

6. Post-op Rehabilitation10
Pt is given Philadelphia collar postoperatively and is
advised to restrict movements of the neck. The pt is
started on liquid diet 1 day after surgery after pt has
bowel sounds. The pt is gradually shifted to soft diet
as tolerated if pt has no pain on deglutition.
Extremity mobilization physiotherapy is started on
postoperative day 1 and pt is made to sit/walk as
tolerated.

Statistical analysis

16
The statistical analysis of the data will be performed by applying the
appropriate tests.

References
1. Wood II G W, Arthrodesis of the spine. Campbells operative
orthopaedics. 12th edition, volume II, pg 1635. (2013).
2. Caspar W1, Barbier DD, Klara PM. Anterior cervical fusion and
Caspar plate stabilization for cervical trauma. Neurosurgery. 1989
Oct;25(4):491-502. (1989).
3. Matz PG1, Holly LT, Groff MW, Vresilovic EJ, Anderson
PA, Heary RF, Kaiser MG, Mummaneni PV, Ryken TC, Choudhri
TF, Resnick DK. Indications for anterior cervical decompression
for the treatment of cervical degenerative radiculopathy. J
Neurosurg Spine. 2009 Aug;11(2):174-82. doi:
10.3171/2009.3.SPINE08720. (2009).
4. Sheperd CS, Young WF. Instrumented Outpatient Anterior
Cervical Discectomy and Fusion: Is it Safe? International Surgery.
2012;97(1):86-89. doi:10.9738/CC35.1. (2012).
5. Lebl DR, Hughes A, Cammisa FP, O’Leary PF. Cervical
Spondylotic Myelopathy: Pathophysiology, Clinical Presentation,
and Treatment. HSS Journal. 2011;7(2):170-178.
doi:10.1007/s11420-011-9208-1. (2011)
6. Jain KK. Anterior approach to the cervical spine. Canadian
Medical Association Journal. 1974;111(1):49-50. (1974).
7. Agrillo U, Faccioli F, Fachinetti P, Gambardella G, Guizzardi G,
Profeta G. Guidelines for the diagnosis and management of the

17
 degenerative diseases of the cervical spine. J Neurol
Sci. 1999;43:11–14. (1999)
8. Bohlman HH, Emery SE, Goodfellow DB, Jones PK. Robinson
anterior cervical discectomy and arthrodesis for cervical
radiculopathy.Long-term follow-up of one hundred and twenty-
two patients. J Bone Joint Surg Am. 1993;75:1298–307. [PubMed]
(1993)
9. 5. Brodke DS, Zdeblick TA. Modified Smith-Robinson procedure
for anterior cervical discectomy and fusion. Spine. 1992;17:S427–
30. (1992).
10.

PROFORMA OF CASE STUDY

Case no.: OPD/IPD NO:
Name:
Age/Sex :
Address
Occupation:
DOA : DOP : DOD:
Chief complaints:

History of Present Illness:

Mechanism of Trauma: Direct / Indirect

Past History: D.M/ T.B. / H.T. / B.A.
: Major Medical/ Surgical history

18
 : Any other joint Arthropathy:
Family History:
Personal History:
Sleep: Appetite:
Bowel& Bladder Habits:
Addictions: Drug allergy:

General Examination:
Built: Nourishment: Weight:
Temp: Pulse:
B.P: R.R.:
E/o Pallor/ icterus/ cyanosis/ oedema/ lymphadenoapathy

Systemic Examination:
CVS- CNS-
RS- GIT-
Local Examination:
Neurological examination:

19
Provisional Clinical Diagnosis:

X-ray:
Investigation: CBC, B.T., C.T., Plasma Glucose
Surgery:
Post-Operative Period:
Follow-up 4 weeks 8 weeks 12 weeks
1. Gait
2. Tingling numbess
3. Sensory deficit

20
 4. Muscle power
5. Reflexes
6. Bladder/bowel involvement

Result Excellent Good Fair Poor

Appendix: 3

INFORMED CONSENT FORM

For submission of Research proposal to

Ethics Committee of PDVVPF’s Medical College

1. I, Mr. / Mrs. ____________________________________, age ______ years

residing at
_____________________________________________________________
hereby give my informed consent to participate in the
_____________________________________________________________
_______________Project
2. There is no compulsion on me to participate in this project and I am giving
my free consent for it.
3. I am ready and willing to undergo all tests and treatments in the present
project.

21
4. I have read and I have been explained the general information and purpose
of the present project.
5. I have been informed / I have read the probable complications while
participating in the present project.
6. I know that I can withdraw from the present project at any time.
7. Any data or analysis of this project will be purely used for scientific purpose
and my name will be kept confidential except when required for any legal
purpose.
8. I can read English / I can understand data read out to me in English.

Signature of parent/Guardian Signature of Volunteer

In case of minor person.
Witnesses: 1.

2.

22
=

23
Facilities Required
 Radiology/Pathology departments
 Well-equipped Operation Theatre with c-arm.

Facilities Available
All required facilities are available in at this hospital.

Signature of PG Student Signature of PG Guide

Signature of Head of the Department

24
 Appendix: 4
UNDERTAKING BY THE INVESTIGATOR
For submission of Research proposal to
Ethics Committee of PDVVPF’s Medical College

1] Full name = Dr. Pranav G Kulkarni

Address = PDVVPF’s Medical college
2] Name and address of the medical college, hospital or other facility where
the clinical trial will be conducted:
PDVVPF’s Medical College & Hospital, Vilad Ghat, Ahmednagar,
Maharashtra-414111
Education, training & experience that qualify the Investigator for the
clinical trial (Attach details including Medical Council registration number,
and /or any other statement(s) of qualification(s) :
M.B.B.S., MMC Registration no. 2013/05/1333.
3] Name and address of all clinical laboratory facilities to be used in the study:
Radiology Department, PDVVPF’s Medical College & Hospital, Vilad
Ghat, Ahmednagar, Maharashtra-414111
4] Name and address of the Ethics Committee that is responsible for approval
and continuing review of the study.

5] Names of the other members of the research team (Co-or sub-Investigators)

who will be assisting the Investigator in the conduct of the investigation(s).
6] Protocol Title and study number (if any) of the clinical trial to be conducted
by the Investigator.
7] Commitments

25
I have reviewed the clinical protocol and agree that it contains all the necessary
information to conduct the study. I will not begin the study until all necessary
Ethics Committee and regulatory approvals have been obtained.

i. I agree to conduct the study in accordance with the current protocol. I

will not implement any deviation from or changes of the protocol
without agreement by the Sponsor and prior review and documented
approval/favorable opinion from the Ethics Committee of the
amendment, except where necessary to eliminate an immediate
hazard(s) to the trial Subjects or when the change(s) involved are only
logistical or administrative in nature.
ii. I agree to personally conduct and/or supervise the clinical trial at my
site.
iii. I agree to inform all Subjects that the drugs are being used for
investigational purposes and I will ensure that the requirements
relating to obtaining informed consent and ethics committee review
and approval specified in the GCP guidelines are met.
iv. I agree to report to the Sponsor all adverse experiences that occur in
the course of the investigation(s) in accordance with the regulatory
and GCP guidelines.
v. I have read and understood the information in the Investigator’s
broacher, including the potential risks and side effects of the drug.
vi. I agree to ensure that all associates, colleagues and employees
assisting in the conduct of the study are suitably qualified and
experienced and they have been informed about their obligations in
meeting their commitments in the trial.
vii. I agree to maintain adequate and accurate records and to make those
records available for audit/inspection by the Sponsor, Ethics

26
 Committee, Licensing Authority or their authorized representatives, in
accordance with regulatory and GCP provisions; I will fully cooperate
with any study related audit conducted by regulatory officials or
authorized representatives of the Sponsor.
viii. I agree to promptly report to the Ethics Committee all changes in the
clinical trial activities and all unanticipated problems involving risks
to human subjects or others.
ix. I agree to inform all unexpected serious adverse events to the Sponsor
as well as the Ethics Committee within seven days of their occurrence.
x. I will maintain confidentiality of the identification of all participating
study patients and assure security and confidentiality of study data.
xi. I agree to comply with all other requirements, guidelines and statutory
obligations as applicable to clinical investigators participating in
clinical trials.
xii. I agree to comply with all other requirements, guidelines and statutory
obligations as applicable to clinical investigators participating in
clinical trials.
8] Signature of Investigators with Name and Date.
Investigators Name Signature

Principal Investigator

Co-Investigator 1
Co-Investigator 2

27
 Appendix: 5
CERTIFICATE from HOD

For submission of Research proposal to

Ethics Committee of PDVVPF’s Medical College

Date:

This is to certify that Research Protocol entitled Study of Functional and

Radiological Outcome of Anterior Cervical Discectomy and Fusion by Smith
Robinson Approach has been presented, discussed and modified accordingly.
Further it is stated that to the best of my knowledge there is no ethical dispute in
this research protocol and therefore may be approved by the Ethics Committee,
PDVVPF’s Medical college and Hospital.

Signature

Name of Head of Department : Dr. Jayant D. Thipse

Department : Orthopaedics

Institute : PDVVPF’s Medical college and Hospital

28
To,
The Chairperson,
Ethical Committee,

Sub: - To approve my Title and Synopsis of Dissertation topic to be

submitted to university.

Respected sir,

I, the undersigned, Dr. Shailesh S. Shevale, am doing M.S.

Orthopedics in your college. With respect to above subject, I wanted to submit
my dissertation topic to university. My topic is: - “Study of Functional and
Radiological Outcome of Anterior Cervical Discectomy and Fusion by
Smith Robinson Approach”.

Thanking you in anticipation.

Yours faithfully,

Dr. Shailesh S Shevale

M.S. Student,

Department of Orthopaedics.

Name of the P.G. PADMASHREE DR. VITHALRAO VIKHE PATIL

College FOUNDATION’S MEDICAL COLLEGE AND
HOSPITAL, AHMEDNAGAR.
Department ORTHOPAEDICS

Name of the Guide Dr. Jayant D. Thipse, PADMASHREE DR.VITHALRAO

& College name VIKHE PATIL FOUNDATION’S MEDICAL COLLEGE
AND HOSPITAL, AHMEDNAGAR.

29