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DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery

Study:

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

Rationale:

n/a

Purpose:

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

Recruiting:
n/a

Condition Intervention Phase
Spinal Injuries
Adhesions
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
ClinicalTrials.gov 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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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