RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES , BANGALORE , KARNATAKA
ANNEXURE IIPROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / Name AND ADDRESS of the candidate / DR .AMIT SINGH
S/O MR. SHARAD SINGH
47 GOVARDHANDHAN DHAM
NAGAR UJJAIN -456010 MADHYA PRADESH
2. / Name of the institution / KEMPEGOWDA INSTITUTE OF
MEDICAL SCIENCES AND RESEARCH CENTRE,
BANGALORE.
3. / Course of study and subject / M.S. ORTHOPAEDICS
4. / Date of admission to course / 31.05.2012
5. / Title of the topic / “FUNCTIONAL OUTCOME OF LUMBO-SACRAL SPONDYLOLISTHESIS - POSTERIOR STABILIZATION WITH MOSS-MIAMI INSTRUMENTATION AND SPINAL FUSION”
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8. / BRIEF RESUME OF INTENDED WORK:
6.1 NEED FOR STUDY:
• Herbiniaux, a Belgian obstetrician is credited with having first described spondylolisthesis. The term spondylolisthesis was used by Kilian in 1854 and is derived from the Greek word spondylos, meaning “vertebra,” and olisthenein, meaning “to slip.”
• Spondylolisthesis is defined as anterior or posterior slipping of one segment of the spine on the next lower segment.
• The prevalence of spondylolisthesis in the general population is approximately 5% and about equal in men and women. Increased slipping usually occurs between the ages of 9 and 15 years and seldom after the age of 20 years. Recent studies shows increased prevalence of spondylolysis in community based population to 11.5%, nearly twice the prevalence of previous plain radiograph studies as compare to CT.
• Male to Female ratio for
– Spondylolysis is 3:1
– Isthmic type of Spondylolisthesis is 2:1
– And degenerative type of Spondylolisthesis is 1:3.
• Even though low back pain is common presentation in case of spondylolysis and spondylolisthesis, no significant association was found between spondylolysis, isthmic and degenerative spondylolysthesis on CT and low back pain.
• Patients usually present with a persistent dull low-back pain with radiculopathy, which increases with activity and decreases with rest, low-back stiffness, tight hamstrings and intermittent claudication. With more severe slips, the trunk becomes shortened and often leads to complete absence of the waistline. These children walk with a peculiar spastic gait, described as a “pelvic waddle” by Newman, because of the hamstring tightness and the lumbosacral kyphosis.
• The initial treatment is conservative, with rest, use of NSAIDs, physical therapy and the wearing of a body brace. Operative management for Lumbar-Sacral Spondylolisthesis is commonly performed via a posterior decompression, reduction and with poster spinal fusion of the slipped vertebra with spinal instrumentation.
• As surgical outcome of lumbo-sacral spondylolisthesis is better than conservative according to literature in accordance with stable reduction and early amelioration of symptoms, hence we wish to undertake this study and try to establish facts regarding surgical management of spondylolisthesis by moss-miami instrumentation and posterior spinal fusion.
6.2 REVIEW OF LITERATURE:
• Spondylolysis is a descriptive term referring to a defect in the pars interarticularis. The defect may be unilateral or bilateral and may be associated with spondylolisthesis. Spondylolisthesis refers to the anterior displacement (translation) of a vertebra with respect to the vertebra caudal to it. This translation may also be accompanied by an angular deformity (kyphosis)1.
• With regards to progression, in patients with isthmic spondylolisthesis the incidence of a spondylolysis may be as high as 70%. The risk of progression from
spondylolysis to spondylolisthesis is reported to be small 4% -5%. The risk factors that increase the likelihood of further slippage are younger age, female sex, presence of spina bifida, wedging of the vertebrae, rounding of the anterior sacral dome and hyperlordosis2.
• During a fifteen-year period a clinical, radiological and in some cases a surgical study has been made of 319 patients suffering from spondylolisthesis, the five etiological factors are described, and the cases are assigned to five groups according to the factor responsible for the slip. In every case slipping is permitted by a lesion of the apparatus which normally resists the forward thrust of the lower lumbar spine—that is, the hook of the neural arch composed of the pedicle, the pars interarticularis and the inferior articular facet engaging caudally over the superior articular facet of the vertebra below.
In Group I - Congenital spondylolisthesis (66 cases)
In Group II - Spondylolytic spondylolisthesis (164 cases)
In Group III - Traumatic spondylolisthesis (3 cases)
In Group IV - Degenerative spondylolisthesis (80 cases)
In Group V - Pathological spondylolisthesis (6 cases)3.
• Fredrickson BE, Baker D, McHolick WJ, Yuan HA, Lubicky JP performed a prospective roentgenographic study to determine the incidence of spondylolysis, spondylolisthesis, or both, in 500 unselected first-grade children from 1955 through 1957.
The families of the children with spondylolysis were followed in a similar manner. The incidence of spondylolysis at the age of six years was 4.4 per cent and increased to 6 per cent in adulthood. The degree of spondylolisthesis was as much as 28 per
cent, and progression of the spondylolisthesis was unusual. The data support the hypothesis that the spondylolytic defect is the result of a defect in the cartilaginous anlage of a vertebra. There is a hereditary pre-disposition to the defect and a strong association with spina bifida occulta. Progression of a slip was unlikely after adolescence4.
• A prospective study of spondylolysis and spondylolisthesis was initiated in 1955 with a radiographic and clinical study of 500 first-grade children. Objective was to determine the natural history of spondylolysis and spondylolisthesis. To conclude subjects with pars defects follow a clinical course similar to that of the general population. There appears to be a marked slowing of slip progression with each decade, and no subject has reached a 40% slip5.
• In the series of 500 children for who radiographs were made at three separate times during their growth. Of the 500 individuals, thirty eventually had a defect. An incidence of 6 per cent by adulthood. None of these had a progression beyond 30 degrees6.
• With mechanical equations it has been established, the pars interarticularis and the ligaments resist together the tensile and shear force, the bending moment if the pars interarticularis is uncracked. If the tensile stress in the pars interarticularis reaches its strength, crack occurs and the spondylolysis is developed. The cracked pars interarticularis is no longer capable of sustaining tension, the tensile force is transferred to the ligament. When the compressive strain of the pars interarticularis reaches its strain limit, the spondylolisthesis does not develop, because the vertebra cannot slip with the unbroken ligaments. If the loading on the pars interarticularis would be decreasing, the cracks close and the pars interarticularis can ossify. If the tensile stress in the ligament reaches its strength and the ligament breaks, the pars interarticularis cracks through, the vertebra slips and the spondylolisthesis develops7.
• Study conducted with 2 year follow up of patient treated with postero-lateral fusion had less pain and better functional outcome then patients treated with exercise programme8.
• A retrospective study of 14 patients with high-grade L5-S1 spondylolisthesis surgically treated with one-stage decompression and posterolateral and interbody fusion (technique of Bohlman and Cook) concluded that posterior decompression of the spinal canal combined with anterior and posterior arthrodesis performed at one stage through a posterior approach is a safe and effective technique for managing severe spondylolisthesis9.
• In a study among a total of 136 patients,129 cases developed solid fusion mass at 8 months post op with failed fusion in 7 cases and all 129 patients that developed solid fusion after postero lateral fusion claimed to have relief of symptoms10.
6.3 OBJECTIVES OF THE STUDY
• Objectives of the study are to evaluate the safety, efficacy and functional outcome of surgical management of spondylolisthesis with moss-miami instrumentation and posterior spinal fusion.
MATERIALS AND METHODS
7.1 SOURCE OF DATA
All cases presenting at KIMS OrthopaedicsOPD and meeting the inclusion and the exclusion criteria as mentioned below, during the study period will be the subject of study.
7.2 METHOD OF COLLECTION OF DATA
INCLUSION CRITERIA:
– Patients of age group >20yrs - <70yrs
– Presenting with low back pain and neurological claudication.
– Diagnosed clinically and confirmed radiologically.
– Non-traumatic spondylolisthesis.
EXCLUSION CRITERIA:
– Grade I Spondylolisthesis with no neurological deficit and no functional disability.
– Spondyloptosis.
– Patients with any other spinal pathology.
– Patients with any associated neurological involvement due to any other diseases.
– Patients who have had earlier surgeries on their spine.
– Patients who do not consent to the study.
– Patients unfit for surgery due to comorbid medical condition
SAMPLE SIZE
20 cases
STUDY DESIGN
Case series
SAMPLE DESIGN
Purposive sampling
DURATION OF STUDY
November 2012 to April 2014.
STUDY PLACE
Department of Orthopaedics, KIMS Hospital, Bangalore.
7.3 METHODOLOGY:
Ø Required data was collected from patients attending opd, during their stay in hospital as inpatients and during their follow-up.
Ø All patients included in study will be assessed clinically with physical examination and confirmed radiologically.
Ø Written and inform consent.
Ø Pre- op investigation done and physician fitness taken.
Ø Decompression, reduction, stabilization and posterior spinal fusion done with moss-miami instrumentation.
Ø Post operative management.
Ø Follow up on 6 weeks, 12 weeks and 24 weeks.
Ø On each visit clinical and radiological evaluation done to assess neurological status, pain, flexion and extension movements at spine and posterior spinal stabilization and fusion.
Ø Functional outcome assessed on the basis of “oswestry disability index”.
7.4 Does study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly
• X-Ray lumbo-sacral spine –Antero- Posterior view and Lateral view
– Pre-operatively
– Immediate post operative period
– Follow up X-Rays at 6 weeks, 12 weeks and 24 weeks
• MRI lumbo-sacral spine.
7.5 Has ethical clearance been obtained from your institution?
Yes
LIST OF REFERENCES:
1. Weinstein, Stuart L.; Buckwalter, Joseph A. The Thoracolumbar Spine Turek's Orthopaedics: Principles and Their Application, 6th Edition;501
2. Sadiq Shahzad, Meir Adam, Hughes S P.F ;Trauma and Orthopaedics, Charing Cross Hospital, Imperial College School of Medicine, London, W6 8RF, United Kingdom ;Surgical management of spondylolistheis; Overview of literature; Neurology India; 2005; Vol 53, Issue-4, 506-511..
3. P. H. Newman and K. H. Stone, The etiology of spondylolisthesis, J Bone Joint Surg British volume – 1963; VOL. 45-B NO 1; 39-59.
4. Fredrickson BE, Baker D, McHolick WJ, Yuan HA, Lubicky JP ,The natural history of spondylolysis and spondylolisthesis ,Journal of bone & joint surgery, American volume; 1984 Jun;66(5):699-707.
5. Beutler WJ, Fredrickson BE, Murtland A, Sweeney CA, Grant WD, Baker D ,The natural history of spondylolysis and spondylolisthesis: 45- Year follow up evaluation, Spine 2003 May 15;28(10):1027-35.
6. RB Winter, The natural history of spondylolysis and spondylolisthesis Journal of Bone & Joint Surgery, American edition.1985; 67:823.
7. ZL Klemencsics and RM Kiss, Biomechanics in the pathogenesis of spondylolysis and spondylolisthesis Orv Hetil, 2001 142:.
8. Moller, Hans MD; Hedlund, Rune MD, PhD, Surgery versus conservative management in adult isthmic spondylolisthesis: A prospective randomized study. Spine. 25(13):1711-1715, July 1, 2000.
9. Roca, Jaime MD; Ubierna, Maria T. MD; Caceres, Enrique MD; Iborra, Miguel MD, One stage decompression And posterolateral and interbody fusion for severe spondylolisthesis: An analysis of 14 patients, Spine. 24(7):709-714, April 1, 1999.
10. Victor Ka-Siong Kho, Wen-Chih Chen, Feb2008, “Postero lateral fusion using laminectomy bone chips in the treatment of lumbar spondylolisthesis.”International Orthopaedics (Societe Internationale de Chirurgie Orthopedique et de Traumatologie,ISCOT), 32(1):115-119
9. / SIGNATURE OF THE CANDIDATE
10. / REMARKS OF THE GUIDE / Treatment modality of spondylolisthesis has evolved over the years. Moss-miami instrumentation with pedicle screw fixation is currently the most widely accepted and standard treatment protocol for our community.
11. / 11.1 NAME AND DESIGNATION OF THE GUIDE. / DR. H.B. SHIVAKUMAR
PROFESSOR
DEPARTMENT OF ORTHOPAEDICS,
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCE AND RESEARCH CENTRE, BANGALORE.
11.2 SIGNATURE
11.3 HEAD OF THE DEPARTMENT / DR. J.N. SRIDHARA MURTHY,
PROFESSOR AND HEAD,
DEPARTMENT OF ORTHOPAEDICS,
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCE AND RESEARCH CENTRE, BANGALORE.
11.4 SIGNATURE
12. / 12.1 REMARKS OF CHAIRMAN AND PRINCIPAL
12.2 SIGNATURE
Thesis Synopsis for MS Orthopaedics, RGUHS 2012 Page 12