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Clinical Trial: Greenwich Lumbar Stenosis SLIP Study
This study is currently recruiting patients.
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Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Spinal Stenosis Spondylolisthesis | Procedure: Lumbar spinal laminectomy Procedure: Lumbar laminectomy with instrumented pedicle screw fusion | Phase III |
MedlinePlus related topics: Spinal Diseases; Spinal Stenosis; Tailbone Disorders
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title: 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
Secondary Outcomes: complication rate; walking capacity; relief of back pain
Expected Total Enrollment: 75
Study start: May 2002; Expected completion: May 2008
Last follow-up: January 2008; Data entry closure: January 2008
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.
Eligibility
Ages Eligible for Study: 50 Years - 80 Years, Genders Eligible for Study: Both
Criteria
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
Location and Contact Information
Ellyn Wasserberger 203-863-3474 EllynW@greenhosp.org
Connecticut
Greenwich Hospital, Greenwich, Connecticut, 06830, United States; Recruiting
Ellyn Wasserberger 203-863-3474 ellynw@greenhosp.org
Zoher Ghogawala, MD, Principal Investigator
Massachusetts
Lahey Clinic, Burlington, Massachusetts, 01805, United States; Recruiting
Subu N Magge, MD, Principal Investigator
Peter K Dempsey, MD, Sub-Investigator
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States; Recruiting
Jean-Valery Coumans, MD, Principal Investigator
Lawrence F Borges, MD, Sub-Investigator
Ohio
Cleveland Clinic Spine Institute, Cleveland, Ohio, 44195, United States; Recruiting
Donna Gamero 216-445-5515 gamerod@ccf.org
Edward C Benzel, MD, Principal Investigator
Richard Schlenk, MD, Sub-Investigator
Rhode Island
Rhode Island Hospital, Providence, Rhode Island, 02903, United States; Recruiting
Frederick Harrington, Jr., MD, Principal Investigator
Zoher Ghogawala, MD, Study Director, Yale University School of Medicine (Greenwich Hospital)
Edward C Benzel, MD, Study Director, Cleveland Clinic Spine Institute (Cleveland Clinic Foundation)
More Information
Publications
Ghogawala Z, Benzel EC, Amin-Hanjani S, Barker FG 2nd, Harrington JF, Magge SN, Strugar J, Coumans JV, Borges LF. Prospective outcomes evaluation after decompression with or without instrumented fusion for lumbar stenosis and degenerative Grade I spondylolisthesis. J Neurosurg Spine. 2004 Oct;1(3):267-72.
Fischgrund JS, Mackay M, Herkowitz HN, Brower R, Montgomery DM, Kurz LT. 1997 Volvo Award winner in clinical studies. Degenerative lumbar spondylolisthesis with spinal stenosis: a prospective, randomized study comparing decompressive laminectomy and arthrodesis with and without spinal instrumentation. Spine. 1997 Dec 15;22(24):2807-12.
Herkowitz HN, Kurz LT. Degenerative lumbar spondylolisthesis with spinal stenosis. A prospective study comparing decompression with decompression and intertransverse process arthrodesis. J Bone Joint Surg Am. 1991 Jul;73(6):802-8.
Record last reviewed: April 2005
Last Updated: April 25, 2005
Record first received: April 25, 2005
ClinicalTrials.gov Identifier: NCT00109213
Health Authority: United States: Institutional Review Board (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-05-03
Source: ClinicalTrials.gov
Cache Date: May 4, 2005
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