Greenwich Lumbar Stenosis SLIP Study

Completed · Phase 3

Conditions studied: Spinal Stenosis, Spondylolisthesis

In brief

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.

Key facts

Study ID

NCT00109213

Run by

Greenwich Hospital

People needed

66

Starts

2002-05-01

Expected to finish

2014-10-01

Last updated by the study team

2015-12-03

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Symptomatic lumbar spinal stenosis and single level grade I spondylolisthesis (3-14 mm)

You may not qualify if…

• 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

Where it is running

• Greenwich Hospital — Greenwich, Connecticut, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Cleveland Clinic Spine Institute — Cleveland, Ohio, United States
• Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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