DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery

Overview

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.

Full Title of Study: “Randomized Controlled Trial of DuraGen Plus® Adhesion Barrier Matrix to Minimize Adhesions Following Lumbar Discectomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 2010

Detailed Description

For more information, please visit www.DuragenStudy.com

Interventions

  • Device: DuraGen Plus Adhesion Barrier Matrix
    • Application of DuraGen Plus Adhesion Barrier Matrix in spine surgery

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
  • No Intervention: 2
    • Control arm is surgery alone (no adhesion barrier)

Clinical Trial Outcome Measures

Primary Measures

  • Radiological, Pain, and Functional Outcome Assessments
    • Time Frame: 6 months
    • Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage). Pain (VAS): Visual Analog Score used to rate the subject’s pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain. Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))*100.

Secondary Measures

  • Radiological, Pain, and Functional Outcome Assessments
    • Time Frame: 12 months
    • Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage). Pain (VAS): Visual Analog Score used to rate the subject’s pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain. Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))*100.

Participating in This Clinical Trial

Inclusion Criteria (Abstracted from clinical protocol):

  • Patients with radicular pain requiring single-level, lumbar hemi-laminectomy or hemilaminotomy procedures with discectomy in the lower lumbar spine – Require initial open lumbar surgery for extruded, prolapsed or bulging intervertebral discs – Requires removal of herniated disc fragment Exclusion Criteria (Abstracted from clinical protocol): – Current or historic open traumatic injury to the spine – Any previous surgery to the lumbar spine or percutaneous tissue destruction or ablation procedures – Women who are nursing, women who are pregnant and women who are planning to become pregnant during the time of the study – Any spinal conditions or systemic diseases that would preclude the patient from participation in the clinical trial – Clinically significant structural disorders – Known positive for HIV – Insulin-dependent Diabetes Mellitus patients – Morbid obesity (Body Mass Index greater than or equal to 40 kg/m2) – History of alcohol or drug abuse within 2 years prior to randomization

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Integra LifeSciences Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Edward Benzel, MD, Principal Investigator, The Cleveland Clinic Spine Institute

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