Greenwich Lumbar Stenosis SLIP Study - Full Text View

Sponsored by:	Greenwich Hospital
Information provided by:	Greenwich Hospital
ClinicalTrials.gov Identifier:	NCT00109213

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 III

MedlinePlus related topics: Spinal Stenosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study
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

Further study details as provided by Greenwich Hospital:

Primary Outcome Measures:

SF-36 (physical component summary score) [ Time Frame: 1 year and 2 year ]
Oswestry Disability Index [ Time Frame: 1 year and 2 year ]

Secondary Outcome Measures:

complication rate [ Time Frame: 30 days ]
walking capacity [ Time Frame: 1 year ]

Estimated Enrollment:	64
Study Start Date:	May 2002
Estimated Study Completion Date:	January 2008

Arms	Assigned Interventions
1: Active Comparator Lumbar Laminectomy without Fusion	Procedure: Lumbar Laminectomy Removal of bone to decompress spinal nerves
2: Active Comparator 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

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

Contacts

Contact: Zoher Ghogawala, MD	203-661-3333	zoher.ghogawala@yale.edu
Contact: Ellyn Wasserberger	203-863-3474	EllynW@greenhosp.org

Locations

United States, Connecticut
Greenwich Hospital	Recruiting
Greenwich, Connecticut, United States, 06830
Contact: Zoher Ghogawala, MD 203-661-3333 zoher.ghogawala@yale.edu
Contact: Ellyn Wasserberger 203-863-3474 ellynw@greenhosp.org
Principal Investigator: Zoher Ghogawala, MD
United States, Massachusetts
Lahey Clinic	Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Subu Magge, MD 781-744-8982
Principal Investigator: Subu N Magge, MD
Sub-Investigator: Peter K Dempsey, MD
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jean-Valery Coumans, MD 617-726-3511
Principal Investigator: Jean-Valery Coumans, MD
Sub-Investigator: Lawrence F Borges, MD
United States, Ohio
Cleveland Clinic Spine Institute	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Edward C Benzel, MD 216-337-0921
Contact: Donna Gamero 216-445-5515 gamerod@ccf.org
Principal Investigator: Edward C Benzel, MD
Sub-Investigator: Richard Schlenk, MD
United States, Rhode Island
Rhode Island Hospital	Completed
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

Greenwich Lumbar Stenosis SLIP Study Homepage This link exits the ClinicalTrials.gov site

Publications:

Ghogawala Z, Benzel EC, Amin-Hanjani S, Barker FG 2nd, Harrington JF, Magge SN, Strugar J, Coumans JV, Borges LF. Prospective outcomes evaluation after decompression with or without instrumented fusion for lumbar stenosis and degenerative Grade I spondylolisthesis. J Neurosurg Spine. 2004 Oct;1(3):267-72.

Fischgrund JS, Mackay M, Herkowitz HN, Brower R, Montgomery DM, Kurz LT. 1997 Volvo Award winner in clinical studies. Degenerative lumbar spondylolisthesis with spinal stenosis: a prospective, randomized study comparing decompressive laminectomy and arthrodesis with and without spinal instrumentation. Spine. 1997 Dec 15;22(24):2807-12.

Herkowitz HN, Kurz LT. Degenerative lumbar spondylolisthesis with spinal stenosis. A prospective study comparing decompression with decompression and intertransverse process arthrodesis. J Bone Joint Surg Am. 1991 Jul;73(6):802-8.

Study ID Numbers:	GH-SLIP-384
Study First Received:	April 26, 2005
Last Updated:	October 31, 2007
ClinicalTrials.gov Identifier:	NCT00109213
Health Authority:	United States: Institutional Review Board

Keywords provided by Greenwich Hospital:

Spinal Stenosis
Lumbar Spine
Decompression

Fusion
Spondylolisthesis
Prospective, randomized clinical trial

Study placed in the following topic categories:

Spinal Diseases
Pathological Conditions, Anatomical
Musculoskeletal Diseases
Constriction, Pathologic

Spondylolisthesis
Bone Diseases
Spinal Stenosis

ClinicalTrials.gov processed this record on January 15, 2009