DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery - Full Text View

Sponsor:	Integra LifeSciences Corporation
Information provided by:	Integra LifeSciences Corporation
ClinicalTrials.gov Identifier:	NCT00387829

Purpose

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.

Condition	Intervention
Spinal Injuries Adhesions	Device: DuraGen Plus Adhesion Barrier Matrix

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Controlled Trial of DuraGen Plus® Adhesion Barrier Matrix to Minimize Adhesions Following Lumbar Discectomy

Resource links provided by NLM:

MedlinePlus related topics: Adhesions Surgery

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Integra LifeSciences Corporation:

Primary Outcome Measures:

Radiological, pain, and functional outcome assessments [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Radiological, pain, and functional outcome assessments [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	October 2006
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine	Device: DuraGen Plus Adhesion Barrier Matrix Application of DuraGen Plus Adhesion Barrier Matrix in spine surgery
2: No Intervention Control arm is surgery alone (no adhesion barrier)

Detailed Description:

For more information, please visit www.DuragenStudy.com

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387829

Show 36 Study Locations

Sponsors and Collaborators

Integra LifeSciences Corporation

Investigators

Principal Investigator:

Edward Benzel, MD

The Cleveland Clinic Spine Institute

More Information

No publications provided

Responsible Party:	Integra LifeSciences Corporation ( Judith O'Grady, RN, MSN, Sr. Vice President, Regulatory Affairs, Quality Assurance, and Clinical Affairs )
Study ID Numbers:	DURA-US-2006-1
Study First Received:	October 12, 2006
Last Updated:	November 17, 2009
ClinicalTrials.gov Identifier:	NCT00387829 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Physiological Effects of Drugs
Estradiol valerate
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Wounds and Injuries
Disorders of Environmental Origin
Adhesions
Reproductive Control Agents

Estradiol 17 beta-cypionate
Hormones
Pharmacologic Actions
Estradiol
Pathologic Processes
Spinal Injuries
Therapeutic Uses
Estradiol 3-benzoate
Back Injuries
Polyestradiol phosphate

ClinicalTrials.gov processed this record on November 20, 2009