DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery

Adhesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00387829
• Other study ID #: DURA-US-2006-1
• Status: Terminated
• Phase: N/A
• First received: October 12, 2006
• Last updated: September 17, 2013
• Start date: October 2006
• Est. completion date: December 2011

Study information

• Verified date: September 2013
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

For more information, please visit www.DuragenStudy.com

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 347
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adhesions
• Spinal Injuries
• Tissue Adhesions

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Spine Source	Beverly Hills	California
United States	University of Virginia	Charlottesville	Virginia
United States	Chicago Institute of Neurosurgery and Neuroresearch	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	University of Cincinnati Medical Center / Mayfield Clinic	Cincinnati	Ohio
United States	Orthopaedic Specialties Spine Center	Clearwater	Florida
United States	The Cleveland Clinic Spine Institute	Cleveland	Ohio
United States	Columbia Orthopedic Group	Columbia	Missouri
United States	Greenwich Neurosurgery/Greenwich Hospital	Greenwich	Connecticut
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Princeton Brain and Spine Care	Langhorne	Pennsylvania
United States	William S. Muir, MD, PC	Las Vegas	Nevada
United States	Bluegrass Orthopedics	Lexington	Kentucky
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	The Back Center	Melbourne	Florida
United States	University of Miami	Miami	Florida
United States	Mission Hospital	Mission Viejo	California
United States	Montana Neuroscience Institute Foundation	Missoula	Montana
United States	Ronderos Neurosurgery Center, Providence Hospital	Mobile	Alabama
United States	University of Medicine and Dentistry of New Jersey	New Brunswick	New Jersey
United States	OSF Saint Francis Medical Center	Peoria	Illinois
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Texas Back Institute	Plano	Texas
United States	Roger Williams Hospital	Providence	Rhode Island
United States	Virginia Commonwealth University Health System	Richmond	Virginia
United States	University of California, San Diego	San Diego	California
United States	Spine Institute	Santa Monica	California
United States	Southeastern Orthopedic Center	Savannah	Georgia
United States	Orthopedics Intl.	Seattle	Washington
United States	Swedish Neuroscience Institute	Seattle	Washington
United States	Interactive Neuroscience Center	Shreveport	Louisiana
United States	Tallahassee Neurological Clinic	Tallahassee	Florida
United States	University of South Florida	Tampa	Florida
United States	Southern California Orthopedic Institute	Van Nuys	California
United States	Central Ohio Neurological Surgery	Westerville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No