Status:
COMPLETED
Greenwich Lumbar Stenosis SLIP Study
Lead Sponsor:
Greenwich Hospital
Conditions:
Spinal Stenosis
Spondylolisthesis
Eligibility:
All Genders
50-80 years
Phase:
PHASE3
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) compressi...
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 instrument...
Eligibility Criteria
Inclusion
- Symptomatic lumbar spinal stenosis and single level grade I spondylolisthesis (3-14 mm)
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00109213
Start Date
May 1 2002
End Date
October 1 2014
Last Update
December 3 2015
Active Locations (5)
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1
Greenwich Hospital
Greenwich, Connecticut, United States, 06830
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Lahey Clinic
Burlington, Massachusetts, United States, 01805
4
Cleveland Clinic Spine Institute
Cleveland, Ohio, United States, 44195