DuraGen Plus® Adhesion Barrier Matrix

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

Who May Be a Candidate

Integra is currently conducting the trial in several locations throughout the United States. These sites are recruiting patients, of either gender, who require a single-level, lumbar disc surgery procedure (hemi-laminectomy or hemi-laminotomy with discectomy) in the area between L4 and S1.

The study is now being conducted at clinical sites nationwide. For additional information, or study locations, please contact DuraGenStudy@verticalhealth.com

This research study is being conducted because adhesions or scars that form on structures, such as nerves and muscles, after surgery are common and may be responsible for chronic pain and limited movement after lumbar discectomy (surgery to repair a ruptured or slipped disc in your back). Scarring is formed as part of the body's natural healing process following surgery. A problem occurs if this scar, called an adhesion, attaches itself to nearby structures. Adhesions can compress or tether to the nerves causing pain, numbness and muscle weakness after back surgery because they prevent the nerves and muscles from moving properly under normal activity.

Unfortunately, it is difficult to predict which patients are at risk for pain resulting from the scar and adhesion formation. Prevention at the time of the initial surgical procedure may be the most effective method to minimize post-operative scarring and reduce the pain from adhesions.

If you will be having an operation on your spine because of a ruptured or "slipped" disc, you may qualify to be in this study if you choose to participate.

Product Being Studied

This study will specifically evaluate the safety and effectiveness of an experimental product, called DuraGen Plus® Adhesion Barrier Matrix, which may help to minimize post-operative scarring and the pain that may result from that scarring.

Clinical Trial Sponsor

This clinical trial is sponsored by Integra LifeSciences Corporation.

Purpose and Objective

Integra LifeSciences Corporation is conducting a prospective, multicenter, randomized, controlled clinical trial to evaluate the safety and effectiveness of DuraGen Plus® as an adhesion barrier in spinal surgery. The purpose of the study is to evaluate the safety, effectiveness, and performance of an investigational product, called DuraGen Plus® Adhesion Barrier Matrix, which may help to minimize post-operative scarring and the pain that may result from that scarring.

Recruiting Locations (United States)

The study is now being conducted at clinical sites nationwide. For additional information, or study locations, please contact DuraGenStudy@verticalhealth.com

Eligibility, Inclusion and Exclusion Criteria

ClinicalTrials.gov Identifier: NCT00387829

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

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

• Lumbar Discectomy: Minimally Invasive Spine Surgery
• Minimally Invasive Surgery a Viable Option for Patients with Herniated Lumbar Disks
• Discharge Instructions for Lumbar Fusion Surgery
• Minimally Invasive Endoscopic Spinal Surgery
• Back Pain: When is Surgery Appropriate?
• Treatment and Prevention of Lumbar Disc Herniations