Clinical trial NCT00387829: DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery
Official title: Randomized Controlled Trial of DuraGen Plus® Adhesion Barrier Matrix to Minimize Adhesions Following Lumbar Discectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Injuries
Adhesions
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2006-10-13
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 comparison to a control group receiving standard care.

Detailed description: For more information, please visit www.DuragenStudy.com

Eligibility 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

Primary outcomes:
measure: Radiological, Pain, and Functional Outcome Assessments
timeFrame: 6 months
Secondary outcomes:
measure: Radiological, Pain, and Functional Outcome Assessments
timeFrame: 12 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Ronderos Neurosurgery Center, Providence Hospital
state: Alabama
city: Beverly Hills
country: United States
facility: Spine Source
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Mission Viejo
country: United States
facility: Mission Hospital
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Santa Monica
country: United States
facility: Spine Institute
state: California
city: Van Nuys
country: United States
facility: Southern California Orthopedic Institute
state: California
city: Greenwich
country: United States
facility: Greenwich Neurosurgery/Greenwich Hospital
state: Connecticut
city: Clearwater
country: United States
facility: Orthopaedic Specialties Spine Center
state: Florida
city: Melbourne
country: United States
facility: The Back Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Savannah
country: United States
facility: Southeastern Orthopedic Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Chicago Institute of Neurosurgery and Neuroresearch
state: Illinois
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Lexington
country: United States
facility: Bluegrass Orthopedics
state: Kentucky
city: Shreveport
country: United States
facility: Interactive Neuroscience Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Columbia
country: United States
facility: Columbia Orthopedic Group
state: Missouri
city: Missoula
country: United States
facility: Montana Neuroscience Institute Foundation
state: Montana
city: Las Vegas
country: United States
facility: William S. Muir, MD, PC
state: Nevada
city: New Brunswick
country: United States
facility: University of Medicine and Dentistry of New Jersey
state: New Jersey
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center / Mayfield Clinic
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Spine Institute
state: Ohio
city: Westerville
country: United States
facility: Central Ohio Neurological Surgery
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Langhorne
country: United States
facility: Princeton Brain and Spine Care
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Roger Williams Hospital
state: Rhode Island
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
city: Seattle
country: United States
facility: Orthopedics Intl.
state: Washington
city: Seattle
country: United States
facility: Swedish Neuroscience Institute
state: Washington
Study officials:
affiliation: The Cleveland Clinic Spine Institute
name: Edward Benzel, MD
role: PRINCIPAL_INVESTIGATOR
References: