Clinical Trials Directory

Trials / Terminated

TerminatedNCT00387829

DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
347 (actual)
Sponsor
Integra LifeSciences Corporation · Industry
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DEVICEDuraGen Plus Adhesion Barrier MatrixApplication of DuraGen Plus Adhesion Barrier Matrix in spine surgery

Timeline

Start date
2006-10-01
Primary completion
2010-12-01
Completion
2011-12-01
First posted
2006-10-13
Last updated
2017-09-07
Results posted
2013-11-20

Locations

36 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00387829. Inclusion in this directory is not an endorsement.