Status:
TERMINATED
A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis
Lead Sponsor:
Synthes USA HQ, Inc.
Conditions:
Spinal Stenosis
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the In-Space compared to the X STOP Interspinous Process Distraction (IPD) device ("X STOP") for the treatment of patients expe...
Eligibility Criteria
Inclusion
- ≥ 50 years in age
- Leg/buttock/groin pain, with or without back pain, that can be completely relieved by flexion such as when sitting in a chair.
- Zurich Claudication Questionnaire Score ≥ 2.0,
- Neurogenic intermittent claudication secondary to moderate lumbar spinal stenosis
- Has completed at least 6 months conservative therapy
Exclusion
- Axial back pain only without leg/buttock/groin pain
- Has had any prior lumbar spine surgery at any level
- Significant scoliosis, defined as Cobb angle \> 10°
- Spondylolisthesis \> Grade 1 or isthmic spondylolisthesis at affected level
- Osteoporosis
- Morbid obesity, defined as BMI \> 40 kg/m2
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00697827
Start Date
June 1 2008
End Date
June 1 2011
Last Update
June 11 2012
Active Locations (10)
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1
The Spine Institute
Santa Monica, California, United States, 90404
2
Yale Orthopedics
New Haven, Connecticut, United States, 06519
3
Institute for Low Back and Neck Care
Minneapolis, Minnesota, United States, 55407
4
Cornell University Hospital
New York, New York, United States, 10021