Greenwich Lumbar Stenosis SLIP Study

Spinal Stenosis Clinical Trial

— SLIP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109213
• Other study ID #: GH-SLIP-384
• Status: Completed
• Phase: Phase 3
• First received: April 26, 2005
• Last updated: December 2, 2015
• Start date: May 2002
• Est. completion date: October 2014

Study information

• Verified date: December 2015
• Source: Greenwich Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 2014
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis
• Spondylolisthesis

Intervention

Procedure:
• Lumbar Laminectomy with Instrumented Pedicle Screw Fusion
Removal of bone to decompress spinal nerves with placement of spinal screws and extra bone to strengthen the spine
• Lumbar Laminectomy
Removal of bone to decompress spinal nerves

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Lahey Clinic	Burlington	Massachusetts
United States	Cleveland Clinic Spine Institute	Cleveland	Ohio
United States	Greenwich Hospital	Greenwich	Connecticut
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Greenwich Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 (Phila Pa 1976). 1997 Dec 15;22(24):2807-12. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SF-36 (physical component summary score)		2 year	No
Secondary	Oswestry Disability Index		2 year, 3 year, 4 year	No
Secondary	Major Complication rate		30 days	No

External Links

•   Greenwich Lumbar Stenosis SLIP Study Homepage