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 Overview

• Status: Terminated
• Conditions: Spinal Injuries; Adhesions
• Intervention / Treatment: Device: DuraGen Plus Adhesion Barrier Matrix

Detailed Description

For more information, please visit www.DuragenStudy.com

• Study Type: Interventional
• Enrollment (Actual): 347
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Ronderos Neurosurgery Center, Providence Hospital
  • California
    • Beverly Hills, California, United States, 90212
      • Spine Source
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Mission Viejo, California, United States, 92691
      • Mission Hospital
    • San Diego, California, United States, 92103
      • University of California, San Diego
    • Santa Monica, California, United States, 90404
      • Spine Institute
    • Van Nuys, California, United States, 91405
      • Southern California Orthopedic Institute
  • Connecticut
    • Greenwich, Connecticut, United States, 06830
      • Greenwich Neurosurgery/Greenwich Hospital
  • Florida
    • Clearwater, Florida, United States, 33756
      • Orthopaedic Specialties Spine Center
    • Melbourne, Florida, United States, 32901
      • The BACK Center
    • Miami, Florida, United States, 33136
      • University of Miami
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Neurological Clinic
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Georgia
    • Savannah, Georgia, United States, 31405
      • Southeastern Orthopedic Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60640
      • Chicago Institute of Neurosurgery and Neuroresearch
    • Peoria, Illinois, United States, 61637
      • OSF Saint Francis Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Bluegrass Orthopedics
  • Louisiana
    • Shreveport, Louisiana, United States, 71119
      • Interactive Neuroscience Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • Missouri
    • Columbia, Missouri, United States, 65205
      • Columbia Orthopedic Group
  • Montana
    • Missoula, Montana, United States, 59802
      • Montana Neuroscience Institute Foundation
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • William S. Muir, MD, PC
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • University of Medicine and Dentistry of New Jersey
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati Medical Center / Mayfield Clinic
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Spine Institute
    • Westerville, Ohio, United States, 43081
      • Central Ohio Neurological Surgery
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • Langhorne, Pennsylvania, United States, 19047
      • Princeton Brain and Spine Care
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • Roger Williams Hospital
  • Texas
    • Plano, Texas, United States, 75093
      • Texas Back Institute
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University Health System
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Neuroscience Institute
    • Seattle, Washington, United States, 98122
      • Orthopedics Intl.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Investigators: Principal Investigator: Edward Benzel, MD, The Cleveland Clinic Spine Institute

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: October 12, 2006
• First Submitted That Met QC Criteria: October 12, 2006
• First Posted (Estimate): October 13, 2006

Study Record Updates

• Last Update Posted (Actual): September 7, 2017
• Last Update Submitted That Met QC Criteria: August 7, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Fibrosis; Cicatrix; Back Injuries; Tissue Adhesions; Spinal Injuries; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate
• Other Study ID Numbers: DURA-US-2006-1