NCT00109213

Greenwich Lumbar Stenosis SLIP Study

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Greenwich Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Spinal Stenosis
• Spondylolisthesis

Interventions

Type	Name	Description
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
PROCEDURE	Lumbar Laminectomy	Removal of bone to decompress spinal nerves

Timeline

• Start date: 2002-05-01
• Primary completion: 2009-09-01
• Completion: 2014-10-01
• First posted: 2005-04-26
• Last updated: 2015-12-03

Locations

5 sites across 1 country: United States