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DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery

Primary Purpose

Spinal Injuries, Adhesions

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DuraGen Plus Adhesion Barrier Matrix
Sponsored by
Integra LifeSciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Injuries

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ronderos Neurosurgery Center, Providence Hospital
  • Spine Source
  • Cedars-Sinai Medical Center
  • Mission Hospital
  • University of California, San Diego
  • Spine Institute
  • Southern California Orthopedic Institute
  • Greenwich Neurosurgery/Greenwich Hospital
  • Orthopaedic Specialties Spine Center
  • The Back Center
  • University of Miami
  • Tallahassee Neurological Clinic
  • University of South Florida
  • Southeastern Orthopedic Center
  • Northwestern University
  • Chicago Institute of Neurosurgery and Neuroresearch
  • OSF Saint Francis Medical Center
  • Bluegrass Orthopedics
  • Interactive Neuroscience Center
  • Johns Hopkins Hospital
  • Columbia Orthopedic Group
  • Montana Neuroscience Institute Foundation
  • William S. Muir, MD, PC
  • University of Medicine and Dentistry of New Jersey
  • University of Cincinnati Medical Center / Mayfield Clinic
  • The Cleveland Clinic Spine Institute
  • Central Ohio Neurological Surgery
  • Penn State Milton S. Hershey Medical Center
  • Princeton Brain and Spine Care
  • Hospital of the University of Pennsylvania
  • Roger Williams Hospital
  • Texas Back Institute
  • University of Virginia
  • Virginia Commonwealth University Health System
  • Orthopedics Intl.
  • Swedish Neuroscience Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

2

Arm Description

Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine

Control arm is surgery alone (no adhesion barrier)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 12, 2006
Last Updated
August 7, 2017
Sponsor
Integra LifeSciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00387829
Brief Title
DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery
Official Title
Randomized Controlled Trial of DuraGen Plus® Adhesion Barrier Matrix to Minimize Adhesions Following Lumbar Discectomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Sponsor voluntarily terminated study
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integra LifeSciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
For more information, please visit www.DuragenStudy.com

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Injuries, Adhesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
347 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
Arm Title
2
Arm Type
No Intervention
Arm Description
Control arm is surgery alone (no adhesion barrier)
Intervention Type
Device
Intervention Name(s)
DuraGen Plus Adhesion Barrier Matrix
Intervention Description
Application of DuraGen Plus Adhesion Barrier Matrix in spine surgery
Primary Outcome Measure Information:
Title
Radiological, Pain, and Functional Outcome Assessments
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Radiological, Pain, and Functional Outcome Assessments
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Benzel, MD
Organizational Affiliation
The Cleveland Clinic Spine Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ronderos Neurosurgery Center, Providence Hospital
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Spine Source
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Mission Hospital
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Spine Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Southern California Orthopedic Institute
City
Van Nuys
State/Province
California
ZIP/Postal Code
91405
Country
United States
Facility Name
Greenwich Neurosurgery/Greenwich Hospital
City
Greenwich
State/Province
Connecticut
ZIP/Postal Code
06830
Country
United States
Facility Name
Orthopaedic Specialties Spine Center
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
The Back Center
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Tallahassee Neurological Clinic
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Southeastern Orthopedic Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Chicago Institute of Neurosurgery and Neuroresearch
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Bluegrass Orthopedics
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Interactive Neuroscience Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71119
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Columbia Orthopedic Group
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65205
Country
United States
Facility Name
Montana Neuroscience Institute Foundation
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
William S. Muir, MD, PC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
University of Medicine and Dentistry of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
University of Cincinnati Medical Center / Mayfield Clinic
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
The Cleveland Clinic Spine Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Central Ohio Neurological Surgery
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Princeton Brain and Spine Care
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Roger Williams Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Texas Back Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Virginia Commonwealth University Health System
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Orthopedics Intl.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Swedish Neuroscience Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

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DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery

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