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Title: Randomized Controlled Trial of DuraGen Plus® Adhesion Barrier Matrix to Minimize Adhesions Following Lumbar Discectomy      
available:
True
dateReleased:
10-12-2006
description:
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.
privacy:
information not available
aggregation:
instance of dataset
ID:
NCT00387829
refinement:
curated
dateModified:
09-17-2013
availability:
available
types:
clinical trial
name:
Device
agent:
DuraGen Plus Adhesion Barrier Matrix
schedulesActivity:
Application of DuraGen Plus Adhesion Barrier Matrix in spine surgery
funders:
Integra LifeSciences Corporation
selectionCriteria:
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
studyGroups:
1
2
types:
Interventional
ID:
DURA-US-2006-1
accessURL: https://clinicaltrials.gov/ct2/show/results/NCT00387829
storedIn:
ClinicalTrial.gov
format:
HTML
accesstypes:
landing page
dateVerified:
20130901
authentication:
none
authorization:
none
creators:
Integra LifeSciences Corporation
homepage: https://clinicaltrials.gov
ID:
SCR:002309
name:
ClinicalTrials.gov

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