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DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery


Randomized Controlled Trial of DuraGen Plus® Adhesion Barrier Matrix to Minimize Adhesions Following Lumbar Discectomy




To evaluate the safety and effectiveness of DuraGen Plus® Adhesion Barrier Matrix as an adhesion barrier in spinal surgery to reduce the extent of peridural fibrosis formation and radicular pain in comparison to a control group receiving standard care.

Study Status: Terminated


Condition Intervention Phase
Spinal Injuries
Device: DuraGen Plus Adhesion Barrier Matrix N/A

Verified by Integra LifeSciences Corporation September, 2013

Sponsored by: Integra LifeSciences Corporation
Information provided by: Integra LifeSciences Corporation identifier: NCT00387829

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

The Cleveland Clinic Spine Institute
Cleveland, Ohio 44195
United States

Edward Benzel, MD., Principal Investigator

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