Greenwich Lumbar Stenosis SLIP Study

Study Overview
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Brief Summary
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The purpose of the study is to determine the proper use of lower back screws and rods (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another (spondylolisthesis). There are two types of operations that surgeons perform for this problem. Some spinal surgeons remove some bone in the back (laminectomy) to decompress the nerves. Other surgeons perform a laminectomy (decompression) as above, but feel that it is also important to strengthen the back by placing screws and rods into the spine and adding more bone to obtain a new bridge of bone away from the nerves (decompression with instrumented fusion). This study aims to test the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long term patient outcomes.

Detailed Description
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There is considerable debate among spinal surgeons regarding the optimal surgical procedure for lumbar spinal stenosis with a grade I spondylolisthesis. The major question is whether or not instrumented pedicle screw fusion should be undertaken when a decompressive laminectomy is performed to relieve neural compression. This multi-center, randomized, prospective clinical study aims to address this question by testing the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long-term patient outcomes.

Official Title
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Greenwich Lumbar Stenosis SLIP Study: A Multi-center, Randomized, Prospective Clinical Trial Comparing Spinal Laminectomy to Laminectomy With Instrumented Pedicle Screw Fusion for Lumbar Stenosis With Grade I Spondylolisthesis

Conditions
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Spinal Stenosis, Spondylolisthesis

Intervention / Treatment
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* Procedure: Lumbar Laminectomy with Instrumented Pedicle Screw Fusion
* Procedure: Lumbar Laminectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic lumbar spinal stenosis and single level grade I spondylolisthesis (3-14 mm) Exclusion Criteria: History of previous lumbar spinal surgery in region of stenosis Gross spinal instability (defined as greater than 3 mm motion on flexion/extension studies) Serious medical illness (ASA Class III or higher) Spondylolisthesis greater than 14 mm or associated with spondylolysis

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Lumbar Laminectomy without Fusion | Procedure: Lumbar Laminectomy<br>* Removal of bone to decompress spinal nerves<br>|
| Active Comparator: 2<br>Lumbar Laminectomy with Pedicle Screw Instrumented Fusion | Procedure: Lumbar Laminectomy with Instrumented Pedicle Screw Fusion<br>* Removal of bone to decompress spinal nerves with placement of spinal screws and extra bone to strengthen the spine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 (physical component summary score) |  | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index |  | 2 year, 3 year, 4 year | 
| Major Complication rate |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fusion, Spinal Stenosis, Lumbar Spine, Decompression, Spondylolisthesis, Prospective, randomized clinical trial