This trial is active, not recruiting.

Conditions spinal stenosis, spondylolisthesis
Treatments lumbar laminectomy with instrumented pedicle screw fusion, lumbar laminectomy
Phase phase 3
Sponsor Greenwich Hospital
Start date May 2002
End date September 2009
Trial size 64 participants
Trial identifier NCT00109213, GH-SLIP-384


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Lumbar Laminectomy without Fusion
lumbar laminectomy
Removal of bone to decompress spinal nerves
(Active Comparator)
Lumbar Laminectomy with Pedicle Screw Instrumented Fusion
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

Primary Outcomes

SF-36 (physical component summary score)
time frame: 1 year and 2 year
Oswestry Disability Index
time frame: 1 year and 2 year

Secondary Outcomes

complication rate
time frame: 30 days
walking capacity
time frame: 1 year

Eligibility Criteria

Male or female participants from 50 years up to 80 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Greenwich Hospital.