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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00109213
Acronym
SLIP
Enrollment
66
Registered
2005-04-26
Start date
2002-05-31
Completion date
2014-10-31
Last updated
2015-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Stenosis, Spondylolisthesis

Keywords

Spinal Stenosis, Lumbar Spine, Decompression, Fusion, Spondylolisthesis, Prospective, randomized clinical trial

Brief 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.

Interventions

PROCEDURELumbar 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

PROCEDURELumbar Laminectomy

Removal of bone to decompress spinal nerves

Sponsors

Greenwich Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
SF-36 (physical component summary score)2 year

Secondary

MeasureTime frame
Oswestry Disability Index2 year, 3 year, 4 year
Major Complication rate30 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026