Status:
TERMINATED
DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery
Lead Sponsor:
Integra LifeSciences Corporation
Conditions:
Spinal Injuries
Adhesions
Eligibility:
All Genders
18-70 years
Phase:
NA
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 co...
Detailed Description
For more information, please visit www.DuragenStudy.com
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT00387829
Start Date
October 1 2006
End Date
December 1 2011
Last Update
September 7 2017
Active Locations (36)
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1
Ronderos Neurosurgery Center, Providence Hospital
Mobile, Alabama, United States, 36608
2
Spine Source
Beverly Hills, California, United States, 90212
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
4
Mission Hospital
Mission Viejo, California, United States, 92691