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Greenwich Lumbar Stenosis SLIP Study (SLIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00109213
Recruitment Status : Completed
First Posted : April 26, 2005
Last Update Posted : December 3, 2015
Information provided by (Responsible Party):
Greenwich Hospital

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.

Condition or disease Intervention/treatment Phase
Spinal Stenosis Spondylolisthesis Procedure: Lumbar Laminectomy with Instrumented Pedicle Screw Fusion Procedure: Lumbar Laminectomy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2002
Actual Primary Completion Date : September 2009
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Active Comparator: 1
Lumbar Laminectomy without Fusion
Procedure: Lumbar Laminectomy
Removal of bone to decompress spinal nerves

Active Comparator: 2
Lumbar Laminectomy with Pedicle Screw Instrumented Fusion
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

Primary Outcome Measures :
  1. SF-36 (physical component summary score) [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. Oswestry Disability Index [ Time Frame: 2 year, 3 year, 4 year ]
  2. Major Complication rate [ Time Frame: 30 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00109213

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United States, Connecticut
Greenwich Hospital
Greenwich, Connecticut, United States, 06830
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Ohio
Cleveland Clinic Spine Institute
Cleveland, Ohio, United States, 44195
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Greenwich Hospital
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Study Director: Zoher Ghogawala, MD Yale University School of Medicine (Greenwich Hospital)
Study Director: Edward C Benzel, MD Cleveland Clinic Spine Institute (Cleveland Clinic Foundation)
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Greenwich Hospital Identifier: NCT00109213    
Other Study ID Numbers: GH-SLIP-384
First Posted: April 26, 2005    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015
Keywords provided by Greenwich Hospital:
Spinal Stenosis
Lumbar Spine
Prospective, randomized clinical trial
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases