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Completed

NCT Number: NCT00109213

Greenwich Lumbar Stenosis SLIP Study

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.

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Key information

Conditions

Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylolisthesis Spondylolysis Spondylosis

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Greenwich Hospital, Greenwich, Connecticut, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumbar Laminectomy with Instrumented Pedicle Screw Fusion

Procedure

Removal of bone to decompress spinal nerves with placement of spinal screws and extra bone to strengthen the spine

Lumbar Laminectomy

Procedure

Removal of bone to decompress spinal nerves

Primary outcomes

  1. SF-36 (physical component summary score)

    Time frame: 2 year

Secondary outcomes

  1. Oswestry Disability Index

    Time frame: 2 year, 3 year, 4 year

  2. Major Complication rate

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Greenwich Hospital

Other

Registry information

Official study 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

Acronym: SLIP

Important dates

Study start
2002
Primary completion
2009
Study completion
2014
First posted
Apr 26, 2005
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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