DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery

Integra LifeSciences

Status

Terminated

Conditions

Spinal Injuries

Adhesions

Treatments

Device: DuraGen Plus Adhesion Barrier Matrix

Study type

Interventional

Funder types

Industry

Identifiers

NCT00387829

DURA-US-2006-1

Details and patient eligibility

About

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.

Full description

For more information, please visit www.DuragenStudy.com

Enrollment

347 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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