DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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For more information, please visit www.DuragenStudy.com

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

Conditions
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Spinal Injuries, Adhesions

Intervention / Treatment
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* Device: DuraGen Plus Adhesion Barrier Matrix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine | Device: DuraGen Plus Adhesion Barrier Matrix<br>* Application of DuraGen Plus Adhesion Barrier Matrix in spine surgery<br>|
| No Intervention: 2<br>Control arm is surgery alone (no adhesion barrier) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological, Pain, and Functional Outcome Assessments | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological, Pain, and Functional Outcome Assessments | 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. | 12 months |