RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES



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|RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES |

|KARNATAKA, BANGALORE |

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|PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION |

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|1 |Name of the candidate and address : |DR. PRASHANTH DHANRAJ |

| | |ROOM NO.42, BMC PG HOSTEL, |

| | |A.V. ROAD CHAMARAJPET, |

| | |BANGALORE -18. |

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|2 |Name of the Institution: |BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BANGALORE-02. |

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|3 |Course of the study and subject: |M.S. in ORTHOPAEDICS. |

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|4 |Date of Admission to Course : |03. 05. 2010 |

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|5 |Title of the Topic : |“ COMPARISION OF OUTCOME IN LUMBAR SPINE INSTABILITY TREATED |

| | |SURGICALLY WITH PEDICLE SCREW FIXATION WITH OR WITHOUT INTERBODY |

| | |FUSION DEVICE (CAGE)” |

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|6 |BRIEF RESUME OF INTENDED WORK: |

| |6.1 Need for study: |

| |Spinal instability is not a single disease but a pathological consequence of a variety of different spine disorders such |

| |as traumatic fractures, metastatic tumors, and degenerative conditions, each with its own epidemiology. |

| |Around the turn of the 20th century, the problem of progressive spinal deformity and disability caused by spinal tuberculosis had |

| |become a focus of clinical inquiry. The problem did not yield itself to the decompressive procedures (eg, laminectomy) developed |

| |in the previous century.  |

| |In 1891, Berthold Hadra devised spinal instrumentation, which mostly consisted of wiring of posterior elements, was employed |

| |sporadically for treatment of spine fractures.   |

| |In 1911, Russell Hibbs and Fred Albee independently developed the concepts and methods for bony fusion of the spine to address the|

| |symptoms of Pott disease. These methods and their subsequent refinements consisted of applying autologous bone (harvested from |

| |laminae, iliac crest, or ribs) to the dorsal surface of spine. |

| |In the 1950s, Paul Harrington pursued his historic work on correction of idiopathic and postpolio scoliosis by applying a |

| |combination of compression and distraction hooks and rods to the lumbar spine. |

| |Harrington later expressed the idea that there is a “race between instrumentation failure and acquisition of spinal fusion.” This |

| |principle and the realization that the problems of pseudarthrosis and hardware failure could be resolved if bone grafting and |

| |instrumentation were used together laid the foundations of modern spine stabilization surgery.  |

| |Although interbody fusions seem to yield better results than classical postero-lateral fusions, biomechanical testing revealed |

| |that anterior column support without instrumentation is the least rigid construct and seems to have no stabilizing effect |

| |immediately after the procedure. Posterior pedicle screw fixation proved to be the most rigid construct, whether or not a |

| |posterior interbody fusion had been associated. Therefore, a classic stand-alone interbody fusion should not be performed, |

| |especially in the face of high biomechanical forces. |

| |In current practice, bone grafting and instrumentation are often used concurrently based on the expectation that internal fixation|

| |of spine enhances the success of bone fusion while a successful bone fusion eliminates the possibility of hardware failure by |

| |reducing the chronic biomechanical stresses on the hardware construct. |

| |A variety of techniques are available for the application of interbody grafts, and each technique has its particular advantages, |

| |disadvantages and complications. Hence I would like to do a comparative study to assess the interbody fusion with (cage) or |

| |without (bone grafting) devices. |

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| |6.2 Review of Literature: |

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| |Early techniques of arthrodesis with use of allograft or autogenous graft and without instrumentation were associated with a high |

| |rate of failure. |

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| |In a classic study by Stauffer and Coventry1, reported patients who had an anterior interbody arthrodesis. Of patients who were |

| |followed clinically for an average of 3.75 years after the procedure, 36 percent had good (76 to 100 percent) relief of pain, 19 |

| |percent had fair (26 to 75 percent) relief and 44 percent had poor (0 to 25 percent) relief. 44 percent patients who were |

| |evaluated radiographically at a minimum of eighteen months postoperatively had a pseudarthrosis. |

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| |In a study, Chitnavis et al2, showed that in (80%) stand-alone PLIF(posterior lumbar interbody fusion) with augmentation of carbon|

| |fiber cage, 2/3 of patients showed no better outcome or fusion rate. Experienced good or excellent outcomes were found at early & |

| |late Follow up . |

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| |In a study, C D Rayet al3, A study on patients fused at 10 of 11 levels, with a reported 80% average clinical improvement and |

| |at 2-year follow-up 40% showed excellent, 25% good, 21% fair, and 14% showed poor results. |

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| |A study by Vamvanij, et al4 ,showed patients operated with 1 of 4 lumbar fusion procedures, outcomes determined by post-op pain |

| |concluded posterior facet fusion provided the highest rate of fusion (88%) & clinical satisfaction (63%). Patients with lumbar |

| |fusion had better clinical outcomes & a better chance of work resumption. |

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| |In a study, Schofferman, et al5, Prospective randomized comparison of ALIF+PS(Anterior lumbar interbody fusion) and ALIF +PS+PLF |

| |with an average follow up of 35 months was done. Outcomes were measured by Numerical rating scale and Oswestry disability index. |

| |Fusion was evaluated with static plain radiographs. 68% pseudoarthroses was noted in PLF(posterior lumbar fusion). Group with |

| |ALIF+PS(pedical screw) had a higher fusion rate and shorter operating time, blood loss and length of stay. |

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| |In a study by, Dennis J. Rivet et al6 ,showed excellent or good 1-year outcome was achieved in 73% of patients; At 1 year, |

| |radiographic fusion was demonstrated in 74% and was statistically related to clinical outcome.Unilateral and bilateral TLIF |

| |involving placement of carbon fiber cages and pedicle screw fixation are effective treatment options in patients with indications |

| |for lumbar arthrodesis. |

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| |6.3 Aims and Objectives of the study: |

| |To assess the functional outcome and to compare the results after surgical fixation with pedicle screw with (cage) or without |

| |(bone grafting) devices. |

| |To assess the duration taken for interbody fusion(radiologically). |

| |To study the post operative complications and failures if there is no fusion. |

| |MATERIALS AND METHODS |

| |7.1 Source of data |

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| |Patients attending in Department of Orthopaedics in teaching hospitals (Victoria hospital and Bowring and Lady Curzon hospital) |

| |attached to Bangalore Medical College and Research Institute from 2010 to 2012,who are diagnosed with instability of spine and |

| |willing for surgery. |

| |7.2 Method of collection of data |

| |Methodology and type of data collected |

| |After obtaining clearance and approval from the institutional ethical committee and patients fulfilling the inclusion / exclusion |

| |criteria will be included in the study after obtaining informed consent. |

| |Informed and written consent |

| |History. |

| |Clinical examination both local and systemic will be done to assess the cause of instability. |

| |Pain and instability will be graded clinically and radiologically using scales7 -Spinal Outcomes Lumbar–History and Demographics |

| |(SOL–HD), SF-36 Bodily Pain Score (SF-36 BPS), visual analog scale (VAS) pain rating, and Oswestry Disability Index (ODI) and |

| |AP,Lateral and F-E radiographs. |

| |Radiological examination using X ray ,CT scan and other imaging modalities. |

| |Investigations –Baseline and others. |

| |Diagnosis-Clinical and radiological. |

| |Surgery- Posterior approach with pedicle screw fixation with (cage) or without (bone grafting) interbody fusion devices will be |

| |explained to the patient and operated accordingly. |

| |Criteria to select cage will be at the discretion of surgeon,according to the severity of instability and the indications for |

| |using cage. |

| |Routine antibiotics and analgesics/anti-inflammatory. |

| |Complications- Peroperative, immediate and late Postoperative period. |

| |Clinical follow-up at 6wks, 3months, 6months, 12months intervals regarding pain, fusion and the functional outcome will be |

| |evaluated, with use of a numerical scale, according to seven parameters: |

| |-The ability to stand, sit, walk, squat, and put on socks and |

| |shoes; the level of recreational activity; and the level of work. The best (lowest) possible score was 7 points,and the worst |

| |(highest) score was 32 points. (An asymptomatic, |

| |or so-called normal, individual would score between 9 and 12 points on this scale.). |

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| |During this time any investigation needed will be done. X-rays will be done regularly in all the visits. CT scan will be done at |

| |baseline, 6 months and 1 year. |

| |Assesment of fusion will be done as per the criteria8. |

| |(1)lack of any visible motion, or less than 3 degrees of intersegmental change, |

| |as seen on flexion and extension radiographs. |

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| |(2) lack of a dark halo around the implant. |

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| |(3) minimum loss of disc-space height, indicating a resistance to collapse of the |

| |cancellous vertebral bone. |

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| |(4) lack of visible fracture of the device, graft, or vertebrae. |

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| |(5) lack of substantial sclerotic changes in the recipient bone bed or the graft. |

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| |(6) visible bone within the fusion cage as seen on Anterior,Posterior or |

| |Ferguson radiographs. |

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| |Inclusion Criteria . |

| |Patients with lumbar instability secondary to either fracture, degeneration and |

| |congenital conditions will be included in the study . |

| |Patient aged more than 18 years will be included in the study. |

| |Patient having symptoms of instability as per defined criteria. |

| |Patient willing to give consent for surgery. |

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| |Exclusion Criteria |

| |Patient with comorbid conditions and not fit for surgery. |

| |Patient with spinal deformities, polio and cerebral palsy. |

| |Patient with systemic infection, previous interbody fusion at target level. |

| |Pregnancy and lactating mother. |

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| |Sample size: Minimum of 20 patients. |

| |Study design: Prospective study. |

| |Study period: November 2010 to October 2012. |

| |Study duration: 2 years. |

| |Place of study: Patients attending the Department of orthopaedics in teaching hospitals (Victoria hospital and Bowring and Lady |

| |Corzon hospital) attached to Bangalore Medical College and Research Institute. |

| |7.3 Does the study require any investigation to be conducted on patients or animals specify – YES only on patients. |

| |7.4 Has the ethical clearance been obtained from ethical committee of your Institution-“YES”. The ethical clearance has been |

| |obtained from ethical committee of BMCRI, Bangalore. |

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| |LIST OF REFERENCES : |

|8 |1. Stauffer and Coventry.Anterior interbody lumbar spine fusion. Analysis of Mayo Clinic series. J. Bone and Joint Surg, June |

| |1972:54-A: 756-768. |

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| |2. Chitnavis B, Barbagallo G, Selway R. Posterior lumbar interbody fusion for revision disc surgery:J Neurosurg (Spine 2) 95: 2001|

| |190–195. |

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| |3. C D Rayet, Smith AJ, Arginteanu M, Moore F, Steinberger A, Camins.Increased incidence of cage migration and nonunion in |

| |instrumented transforaminal lumbar interbody fusion with bioabsorbable cages. M.J Neurosurg Spine. 2010 Sep;13(3):388-93. |

| |4. Vamvanij V, Fredrickson BE, Thorpe JM .For the performance of fusion procedures for degenerative disease of lumbar spine. Part |

| |11: interbody fusion techniques for lumbar fusion .J Neurosurg: Spine;2004: 2:692–699. |

| |5. Schofferman J, Slosar P, Reynolds J.For the performance of fusion procedures for degenerative disease of the lumbar spine. Part|

| |11: interbody techniques for lumbar fusion. J Neurosurg: Spine;2004: 2:92–99. |

| |6. Dennis J. Rivet, M.D, David Jeck, M.D., James Brennan, M.D, Adrian Epstein, B and Carl Lauryssen, M.D. Clinical outcomes and |

| |complications associated with pedicle screw fixation—augmented lumbar interbody fusion. J Neurosurg: Spine;2005:1:67-72. |

| |7. Paul c. Mcafee. Current Concepts Review - Interbody Fusion Cages in Reconstructive, Operations on the Spine,J Bone Joint Surg |

| |Am. 1999;81:859-80. |

| |8. Paul M. Arnold, MD, Stephen Robbins, MD, Wayne Paullus, MD, Stephen Faust, MD. Clinical Outcomes of Lumbar Degenerative Disc |

| |Disease Treated With Posterior Lumbar Interbody Fusion Allograft Spacer: The American journal of orthopaedics.July 2009 : 112. |

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|9 |Signature of the candidate | |

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|10 |Remarks of the guide |“Considerable controversy existed regarding interbody v/s posterior fusion, |

| | |however with good results achieved by interbody fusion,its necessary to identify |

| | |the ideal grafting technique for interbody fusion. Hence this comparative study” |

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|11 |Name and Designation of : |DR. MANOJ KUMAR H V, MS (Ortho) |

| |Guide |PROFESSOR |

| | |DEPARTMENT OF ORTHOPAEDICS |

| | |BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |

| | |BANGALORE:560002 |

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| |11.2 Signature | |

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| |11.3 Co-Guide |DR. BALAJI PAI, MS (Gen surg),DNB(Neuro surg) |

| | |ASSOCIATE PROFESSOR OF NEUROSURGERY |

| | |BANGALORE MEDICAL COLLEGE AND |

| | |RESEARCH INSTITUTE |

| | |BANGALORE 560002. |

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| |11.4 Signature | |

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| |11.5 Head of the Department |DR. VIJAY KUMAR |

| | |MS (Ortho) PROFESSOR AND HOD |

| | |DEPARTMENT OF ORTHOPAEDICS |

| | |BANGALORE MEDICAL COLLEGE AND |

| | |RESEARCH INSTITUTE |

| | |BANGALORE:560002 |

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| |11.6 Signature | |

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|12 |12.1 Remarks of chairman and Principal | |

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| |12.2 Signature | |

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