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DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery

NCT00387829 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 347

Last updated 2017-09-07

Study results available
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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.

Conditions

  • Spinal Injuries
  • Adhesions

Interventions

DEVICE

DuraGen Plus Adhesion Barrier Matrix

Application of DuraGen Plus Adhesion Barrier Matrix in spine surgery

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Edward Benzel, MD · The Cleveland Clinic Spine Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2010-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00387829 on ClinicalTrials.gov