INDEPENDENCE Spacer for Lumbar Fusion
NCT02299323 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30
Last updated 2016-08-10
Summary
The primary objective of this study is to evaluate radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction following circumferential fusion using the INDEPENDENCE® integrated plate and spacer with REVOLVE® Stabilization System for the treatment of severe low back pain due to lumbar disc degeneration unresponsive to 6 months of non-operative treatment.
Conditions
- Degenerative Disc Disease
Interventions
- DEVICE
-
INDEPENDENCE
Lumbar Integrated plate and spacer, with percutaneous screws and rods.
Sponsors & Collaborators
-
Globus Medical Inc
lead INDUSTRY
Principal Investigators
-
Christopher Chaput, MD · Scott & White Healthcare
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2016-08-31
- Completion
- 2016-08-31
Countries
- United States
Study Locations
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