SYNOPSIS
Rajiv Gandhi University of Health Sciences, Bangalore,
Karnataka
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Synopsis of Dissertation
”STUDY OF LUMBAR DISCECTOMY BY FENESTRATION TECHNIQUE”
Submitted by
Dr GANESH M T, MBBS
POST GRADUATE STUDENT IN ORTHOPAEDICS
Under the guidance of
Dr.Gunnaiah.K.G. D ortho, MS Ortho,
PROFESSOR & HOD
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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 OF DISSERTATION
| | | |
|1 |NAME OF THE CANDIDATE AND ADDRESS |DR GANESH M T |
| |( in block letters) |P.G IN ORTHOPAEDICS |
| | |AIMS |
| | |BG NAGARA, BELLUR |
| | | |
|2 |NAME OF THE INSTITUTION |ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES, B.G.NAGARA. |
| | | |
|3 |COURSE OF STUDY AND SUBJECT |M.S.IN ORTHOPAEDICS |
| | | |
|4 |DATE OF ADMISSION TO COURSE |3RD MAY 2010 |
| | | |
|5 |TITLE OF THE TOPIC |”STUDY OF LUMBAR DISCECTOMY BY FENESTRATION TECHNIQUE” |
| | | |
|6 |BRIEF RESUME OF INTENEDED WORK | |
| | | |
| |6.1 NEED FOR THE STUDY | |
| | |APPENDIX I |
| |6.2 REVIEW OF LITERATURE | |
| | | |
| |6.3 OBJECTIVES OF THE STUDY | |
| | | |
| | | |
|7 |MATERIALS AND METHODS |APPENDIX II |
| | |
| |7.1 SOURCE OF DATA : DEPARTMENT OF ORTHOPAEDICS |
| | |
| |SRI ADICHUNCUNAGIRI INSTITUTE OF MEDICAL SCIENCES |
| | |
| |7.2 DOES THE STUDY REQUIRE ANY |
| |INVESTIGATIONS OR INTERVENTIONS YES |
| |TO BE CONDUCTED ON PATIENTS OR OTHER APPENDIX IIB |
| |ANIMALS, IF SO PLEASE DESCRIBE BRIEFLY |
| | | |
| |HAS ETHICAL CLEARANCE BEEN OBTAINED FORM YOUR INSTITUTION IN CASE OF 7.2 |YES |
| | | |
|8 |LIST OF REFERENCES (ABOUT 4-6) |APPENDIX III |
| | | |
|9 |SIGNATURE OF CANDIDATE | |
| | | |
|10 |REMARKS OF THE GUIDE |SINCE BACK PAIN DUE TO DISC PROLAPSE AFFECTING LUMBAR REGION IS |
| | |MORE COMMON IN RURAL AREAS, DISCECTOMY BY FENESTRATION TECHNIQUE |
| | |IS IDEAL IN RURAL SET UP WHERE THEY CANNOT AFFORD FOR ENDOSCOPIC |
| | |DISCECTOMY |
| | | |
|11 |NAME & DESIGNATION OF | |
| | | |
| |(IN BLOCK LETTERS) | |
| | | |
| |11.1 GUIDE |DR GUNNAIAH K G |
| | |M.B.B.S ,D ORTHO ,M.S ORTHO |
| | |PROFESSOR AND H.O.D |
| | |DEPARTMENT OF ORTHOPAEDICS, |
| | |SRI ADICHUNCHUNAGIRI |
| | |INSTITUTE OF MEDICAL SCIENCES |
| | | |
| |11.2 SIGNATURE | |
| | | |
| |11.3 CO-GUIDE (IF ANY) |NIL |
| | NAME : | |
| | SIGNATURE : | |
| | | |
| |11.4 REMARKS | |
| | | |
| | | |
| | | |
| | | |
| | | |
| |11.5 HEAD OF DEPARTMENT |DR GUNNAIAH K G |
| | |M.B.B.S ,D ORTHO ,M.S ORTHO |
| | |PROFESSOR AND H.O.D |
| | |DEPARTMENT OF ORTHOPAEDICS, |
| | |SRI ADICHUNCHUNAGIRI |
| | |INSTITUTE OF MEDICAL SCIENCES |
| | | |
| |11.6 SIGNATURE | |
| | | |
| |12.1 REMARKS OF CHAIRMAN AND PRINCIPAL | |
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| | | |
| | | |
| |12.2 SIGNATURE | |
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APPENDIX- I
6. BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
Low back pain due to lumbar disc prolapse is the major cause of morbidity through out the world affecting mainly the young adults. Lifetime incidence of low back pain is 50-70 % with incidence of sciatica more than 40 %.
The social and domestic environment prevalent, and personal habits such as defaecation of an Indian patient, it is not possible for the patient to get absolute bed rest which is the sheet anchor of conservative treatment.
Since backache are common in the rural people due to heavy weight lifting, agricultural work, disc lesions are so common, discectomy by fenestration technique is ideal for rural people where they cannot afford for endoscopic discectomy.
Intervertebral disc prolapse occurs predominately in L4-L5 & L5-S1 level. Detailed history, clinical examination supplemented by relevant radiological investigations can differentiate herniated lumbar disc prolapse from other causes of low back pain and sciatica.
This technique will not hamper stability of the spine and they can return work within 10-15 days with light work in 2-3 months. The outcome of surgery depends on many factors, such as careful selection of patients, existing neurological deficit at the time of admission, and nature of the occupation.
6.2 REVIEW OF LITERATURE
Humans have been plagued by back and leg pain since the beginning of recorded history. The early Greeks recognized the symptoms as a disease and prescribed rest and massage for ailment. In the 1500 BC Edwin Smith Papyrus described back strain, but does not include the treatment rendered by Egyptians. Hippocrates (460-370 BC) described the sciatic nerve. Aureliances in 5th century described the symptoms of sciatica.
In 1881 Forst described the test “straight leg rising test” or Lasegue’s sign and attributed this to Lasegue, his teacher. The first disc prolapse operation falsely accredited to Mixter and Brar has been conducted by Oppenhain and Krause in 1909 in Berlin but interpreted it as an enchondroma of spinal disc1,2.
Goldwait in 1911 attributed back pain to posterior displacement of the disc3,4,5.
After many studies, the classical study of Mixter and Brar (1934), finally led to the conclusion that a laminectomy with decompression and extraction of herniated lumbar disc could improve the suffering caused by sciatic pain6.
In 1939, Semmen presented a new procedure to remove the ruptured IV
disc that included subtotal laminectomy and retraction of dural sac to expose the disc and to remove the ruptured disc with the patient under local anaesthesia7.
Love(1939) described extradural removal of herniated disc and devised interlaminar fenestration for treatment of lumbar disc prolapse8.
White(1969) also observed that a convalescence of more than 6 weeks following conservative treatment was of little value and was discouraging to the patient. In a statistical study of 444 men in four years he found that only 40 percent could return to their work in one year and 67 percent at the end of two years9.
Surgical removal of the offending disc offers a simple and effective solution in the management of severe sciatic pain and this method has established its position a reasonably safe procedure with satisfactory results in most of the patients(Spangfort 1972)10.
In 1982, Spengler described limited disc excision, only the ligamentum flavum and if necessary small portion of lamina inferiorly is removed to expose the prolapsed disc space and the extruded disc were removed11.
Nagi, in 1985 reported 93.5% good to excellent result with discectomy by fenestration method and found it to be an extremely satisfactory method12. His criteria for surgery were
• Accentuation of symptoms with cough/sneezing
• Position of comfort – hip and knee flexion
• Positive SLR.
• Restriction of spinal movements
• Spinal tenderness.
Tullberg studies the difference in the results between microsurgical discectomy and standard procedure in a set of 60 patients with single level lumbar disc herniation. He found that the microscope had no effect on the results of the surgery and so the decision to use the microscope was to be left to the operating surgeon13.
Michel Newman in 1995 did outpatient conventional fenestration and disc excision in 75 cases and concluded that outpatient surgery is a practical alternative for selected patients requiring disc surgery14.
Study comprised of 50 patients who underwent lumbar discectomy over a two-year period, from January 1998 to December 1999, showed that Interlaminar discectomy without laminotomy is a safe, effective and reliable surgical technique for treating properly selected patients with herniated lumbar disc at L4–5 and L5–S1 levels15.
Unilateral transflaval discectomy was the most frequently performed procedure and was expected to be the most effective, whereas percutaneous laser disc decompression was expected to be the least effective16.
6.3 AIMS AND OBJECTIVES OF THE STUDY
To study and evaluate the clinical outcome of surgical treatment of lumbar disc prolapse by fenestration technique. Since there is no significant difference between endoscopic discectomy or fenestration and discectomy, it is preferable to opt discectomy by fenestration technique because extensive laminectomy causes destabilization of spine.
APPENDIX II
7. MATERIALS AND METHODS
1. SOURCE OF DATA:
Patients having back pain with radiculopathy, who are admitted in sri adichunchanagiri institute of medical sciences, will be taken for study after obtaining their consent.
INCLUSION CRITERIA:
1. The patient with predominant unilateral leg pain extending below the knee that has been present for at least 6 weeks.
2. Patients with low back pain with radiculopathy with neurological deficits which is not relieved by conservative measures.
3. Patients with less than 3 level disc prolapse.
EXCLUSION CRITERIA:
1. Patients with multiple level disc prolapse.
2. Patients with spinal canal stenosis.
3. Patients with traumatic disc prolapse.
4. Patients with disc lesion along with spondylolisthesis.
5. Patients who are medically unfit for surgery.
APPENDIX – II B
1. Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly
Yes,
1. X-ray of the lumbosacral spine
- Ap view
- Lateral view
2. MRI scan lumbosacral spine
3. Routine investigation to evaluate fitness for surgery.
APPENDIX-IIC
PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL
| | SECTION A | |
| | | |
|a |TITLE OF THE STUDY |”STUDY OF LUMBAR DISCECTOMY BY FENESTRATION TECHNIQUE” |
| | | |
|b |PRINCIPLE INVESTIGATOR ( NAME AND DESIGNATION ) |DR GANESH M T |
| | |POST GRADUATE STUDENT IN ORTHOPAEDICS |
| | |A.I.M.S ,B.G.NAGAR |
| | | |
|c |CO-INVESTIGATOR |DR GUNNAIAH K G |
| |(NAME AND DESIGNATION) |M.B.B.S ,D ORTHO ,M.S ORTHO |
| | |PROFESSOR AND H.O.D |
| | |DEPARTMENT OF ORTHOPAEDICS, |
| | |SRI ADICHUNCHUNAGIRI |
| | |INSTITUTE OF MEDICAL SCIENCES,B.G. NAGARA |
| | | |
|d |NAME OF COLLABORATING DEPARTMENT /INSTITUTIONS |NO |
| | | |
|e |WHETHER PERMISSION HAS BEEN OBTAINED FROM THE HEADS OF COLLABORATING | |
| |DEPARTMENT & INSTITUTION | |
| | |NA |
| | | |
| |SECTION – B | |
| | | |
| |SUMMARY OF THE PROJECT | |
| | | |
| | | |
| | |APPENDIX I |
| | | |
| | | |
| | | |
| |SECTION – C | |
| | | |
| |OBJECTIVES OF THE STUDY | |
| | | |
| |SECTION – D | |
| | |APPENDIX II |
| |METHODOLOGY | |
| | | |
|A |WHERE THE PROPOSED STUDY WILL BE UNDERTAKEN |DEPARTMENT OF ORTHOPAEDICS |
| | |S.A.H & R.C.,B.G.NAGARA |
| | | |
|B. |DURATION OF THE PROJECT |18 MONTHS FROM NOV 2010 |
| | | |
|C |NATURE OF THE SUBJECT: | |
| |DOES OF 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? | |
| |DOES THE STUDY INVOLVE PREGNANT WOMEN? |NO |
| | | |
| | |NO |
| | | |
|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 |NO |
| |PER SESSION ? | |
| | | |
|E |IS THE STUDY A PART OF MULTI CENTRAL TRIAL? |NO |
| | | |
| | | |
|F |IF YES, WHO IS THE COORDINATOR ? |NA |
| | | |
| |(NAME AND DESIGNATION) | |
| | | |
| |HAS THE TRIAL BEEN APPROVED BY THE ETHICS, COMMITTEE OF THE OTHER CENTERS? |- |
| | | |
| |IF THE STUDY INVOLVES THE USE OF DRUGS PLEASE INDICATE WHETHER. | |
| | | |
| |I. THE DRUG IS MARKETED IN INDIA FOR |- |
| |THE INDICATION IN WHICH IT WILL BE | |
| |USED IN THE STUDY. | |
| | | |
| |II, THE DRUG IS MARKETED IN INDIA BUT |NA |
| |NOT FOR THE INDICATION IN WHICH IT | |
| |WILL BE USED IN THE STUDY | |
| | | |
| |III. THE DRUG IS ONLY USED FOR |NA |
| |EXPERIMENTAL USE IN HUMANS. | |
| | | |
| | | |
| | |NA |
| |IV. CLEARANCE OF THE DRUG 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. | |
| | | |
| |PHASE ONE AND TWO CLINCIAL TRIALS |NA |
| | | |
| |EXPERIMENTAL USE IN –PATIENTS | |
| |AND HEALTHY VOLUNTEERS. | |
| | | |
|G |HOW DO YOU PROPOSE TO OBTAIN THE DRUG TO BE USED IN THE STUDY? | |
| | | |
| |-4 GIFT FROM A DRUG COMPANY | |
| |-5 HOSPITAL SUPPLIES |NA |
| |-6 PATIENTS WILL BE ASKED TO PURCHASE | |
| |-7 OTHER SOURCE (EXPLAIN) | |
| | | |
|H |FUNDING (IF ANY) FOR THE PROJECT PLEASE STATE | |
| | | |
| |-8 NONE | |
| |-9 AMOUNT |NO |
| |-10 SOURCE | |
| |-11 TO WHOM PAYABLE | |
| | | |
|I |DOES ANY AGENCY HAVE A VESTED INTEREST IN THE OUT COME OF THE | |
| |PROJECT? |NO |
| | | |
|J |WILL DATA RELATING TO SUBJECT/CONTROLS BE STORED IN A COMPUTER? |YES |
| | | |
|K |WILL THE DATA ANALYSIS BE DONE BY | |
| | | |
| |-12 THE RESEARCHER? |YES |
| | | |
| |-13 THE FUNDING AGENT |NO |
| | | |
|L |WILL TECHNICAL /NURSING HELP BE REQUIRED FROM THE STAFF OF HOSPITAL. | |
| | |NO |
| |IF YES, WILL IT INTERFERE WITH THEIR DUTIES? | |
| | |NO |
| |WILL YOU RECRUIT OTHER STAFF FOR THE DURATION OF THE STUDY? | |
| | | |
| |IF YES GIVE DETAILS OF |NO |
| | | |
| | | |
| |DESIGNATION | |
| |QUALIFICATION | |
| |NUMBER |NA |
| |DURATION OF EMPLOYMENT |NA |
| | |NA |
| | |NA |
| | | |
|M |WILL INFORMED CONSENT BE TAKEN ? IF YES | |
| | | |
| |WILL IT BE WRITTEN INFORMED CONSENT: | |
| | | |
| |WILL IT BE ORAL CONSENT? |YES , CONSENT WILL BE |
| | | |
| |WILL IT BE TAEKN FROM THE SUBJECT THEMSELVES? |TAKEN FROM THE PATIENT |
| | | |
| |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 COMMITTEE,
A.I.M.S., B.G.NAGARA
DATE:
APPENDIX III
8. LIST OF REFERENCES
1. Loew S Casper W. Surgical approach to lumbar disc herniations
Adv. Standards Neurosurg. 1978; 5: 153-74.
2. Hedtmann A. Dos Sog. Postdiskotomiessyndrom: Fehlschlage der bandscheiben-Operation? Z Orthop. 1992; 130: 456-66.
3. Campbell Operative orthopedics 10th ed, Vol. 2, page- 1955-2028.
4. Finesson BE. Lumbar disc excision – Schidesk H.K., Sweet W.H. (eds).
Operative Neurosurgical Technique, 3rd Ed., 1905 – 1924, 1995.
5. Abramovitz ZN, Neff S. Lumbar Disc Surgery: Results of prospective lumbar discectomy study of joint section on disorders of spine of peripheral nerves of American Association of Neurological surgeons and Congress of neurological Surgeons. Neurosurgery 29: 301 – 308, 1991.
6. Mixter WJ, Barr JS. Rupture of intervertebral disc with involvement of spinal canal. New Eng J Med. 1934; 211: 210-14.
7. Rothman RH, Simeone FA. The Spine, 2nd ed. Philadelphia: Saunders, 1982.
8. Love JG. Root pain resulting from intraspinal protrusion of vertebral discs:
diagnosis and treatment. J Bone Joint Surg. 1939; 19: 776-80.
9. White, A. W. M. (1969) : Low back pain in men receiving workmens compensation. J Bone Joint Surg.(Br.), 51, 778-82.
10. Spangfort E.V. 1972: The Lumbar disc herniation. A computer aided analysis of 2054 operations. Acta ortho. Scand. Suppl., 142, 5-78.
11. Dan M. Spengler, M D, Results with limited disc excision: Spine 7:604- 607, 1982.
12. Nagi ON, Sethi A, Gill SS. Early results of discectomy by fenestration technique in lumbar disc prolapsed. Ind J Orthop. 1985; 19(1): 15-9.
13. Tycho Tullberg, MD, Johan Isacson, Does Microscopic Removal of Lumbar Disc Herniation Lead To Better Results Than The Standard Procedure, Spine, Vol 18, number 1, 1993.
14. Michael H. Newman M D, Outpatient conventional laminotomy and disc
excision. Spine 1995 Vol 20, no 3, pp 353-355.
15. Manish Garg and Sudhir Kumar. Interlaminar discectomy and selective
foraminotomy in lumbar disc herniation. Journal of Orthopaedic Surgery 2001, 9(2): 15–18.
16. Mark P. Arts, M.D., Wilco C. Peul, M.D., Bart W. Koes, Ph.D., Ralph T. W.M. Thomeer, Ph.D., and for the Leiden–The Hague Spine Intervention Prognostic Study (SIPS) Group. Management of sciatica due to lumbar disc herniation in the Netherlands:Journal of Neurosurg: Spine Jul 2008, Vol. 9, No. 1, Pgs 32-39: 32-39.
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