Greenwich Lumbar Stenosis SLIP Study

Greenwich Lumbar Stenosis SLIP Study

This study is currently recruiting patients.
Verified by Greenwich Hospital May 2005

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

clinical trials 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 spinal laminectomy
 Procedure: Lumbar laminectomy with instrumented pedicle screw fusion
 Phase III

 

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, 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)
  • Oswestry Disability Index

Secondary Outcome Measures: 
  • complication rate
  • walking capacity
  • relief of back pain

Total Enrollment:  75

Study start: May 2002;  Expected completion: January 2008

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.

clinical trials Eligibility

Ages Eligible for Study:  50 Years   -   80 Years,  Genders Eligible for Study:  Both
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

clinical trials Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00109213
Zoher Ghogawala, MD      203-661-3333    zoher.ghogawala@yale.edu
Ellyn Wasserberger      203-863-3474    EllynW@greenhosp.org

United States, Connecticut
Greenwich Hospital, Greenwich,  Connecticut,  06830,  United States; Recruiting
Zoher Ghogawala, MD  203-661-3333    zoher.ghogawala@yale.edu 
Ellyn Wasserberger  203-863-3474    ellynw@greenhosp.org 
Zoher Ghogawala, MD,  Principal Investigator

United States, Massachusetts
Lahey Clinic, Burlington,  Massachusetts,  01805,  United States; Recruiting
Subu Magge, MD  781-744-8982 
Subu N Magge, MD,  Principal Investigator
Peter K Dempsey, MD,  Sub-Investigator

Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting
Jean-Valery Coumans, MD  617-726-3511 
Jean-Valery Coumans, MD,  Principal Investigator
Lawrence F Borges, MD,  Sub-Investigator

United States, Ohio
Cleveland Clinic Spine Institute, Cleveland,  Ohio,  44195,  United States; Recruiting
Edward C Benzel, MD  216-337-0921 
Donna Gamero  216-445-5515    gamerod@ccf.org 
Edward C Benzel, MD,  Principal Investigator
Richard Schlenk, MD,  Sub-Investigator

United States, Rhode Island
Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States; Recruiting
Frederick Harrington, Jr., MD  401-521-9999 
Frederick Harrington, Jr., MD,  Principal Investigator

Study chairs or principal investigators

Zoher Ghogawala, MD,  Study Director,  Yale University School of Medicine (Greenwich Hospital)   
Edward C Benzel, MD,  Study Director,  Cleveland Clinic Spine Institute (Cleveland Clinic Foundation)   

clinical trials More Information

Greenwich Lumbar Stenosis SLIP Study Homepage

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.

Last Updated: 06/13/2007
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