Greenwich Lumbar Stenosis SLIP Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Greenwich Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Greenwich Hospital
ClinicalTrials.gov Identifier:
NCT00109213
First received: April 26, 2005
Last updated: March 27, 2013
Last verified: September 2009
  Purpose

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 Intervention Phase
Spinal Stenosis
Spondylolisthesis
Procedure: Lumbar Laminectomy with Instrumented Pedicle Screw Fusion
Procedure: Lumbar Laminectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Greenwich Hospital:

Primary Outcome Measures:
  • SF-36 (physical component summary score) [ Time Frame: 1 year and 2 year ] [ Designated as safety issue: No ]
  • Oswestry Disability Index [ Time Frame: 1 year and 2 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complication rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • walking capacity [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: May 2002
Estimated Study Completion Date: July 2014
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109213

Locations
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
Investigators
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)
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Greenwich Hospital
ClinicalTrials.gov Identifier: NCT00109213     History of Changes
Other Study ID Numbers: GH-SLIP-384
Study First Received: April 26, 2005
Last Updated: March 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Greenwich Hospital:
Spinal Stenosis
Lumbar Spine
Decompression
Fusion
Spondylolisthesis
Prospective, randomized clinical trial

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Spondylolisthesis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on September 18, 2014