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

April 26, 2005
March 27, 2013
May 2002
September 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • SF-36 (physical component summary score)
  • Oswestry Disability Index
Complete list of historical versions of study NCT00109213 on ClinicalTrials.gov Archive Site
  • complication rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • walking capacity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • complication rate
  • walking capacity
  • relief of back pain
Not Provided
Not Provided
 
Greenwich Lumbar Stenosis SLIP Study
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Spinal Stenosis
  • Spondylolisthesis
  • 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
  • Procedure: Lumbar Laminectomy
    Removal of bone to decompress spinal nerves
  • Active Comparator: 1
    Lumbar Laminectomy without Fusion
    Intervention: Procedure: Lumbar Laminectomy
  • Active Comparator: 2
    Lumbar Laminectomy with Pedicle Screw Instrumented Fusion
    Intervention: Procedure: Lumbar Laminectomy with Instrumented Pedicle Screw Fusion

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
64
July 2014
September 2009   (final data collection date for primary outcome measure)

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
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00109213
GH-SLIP-384
Yes
Greenwich Hospital
Greenwich Hospital
Not Provided
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)
Greenwich Hospital
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP