DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery

Condition(s) targeted: Spinal Injuries; Adhesions

Intervention: DuraGen Plus Adhesion Barrier Matrix (Device)

Phase: N/A

Status: Recruiting

Sponsored by: Integra LifeSciences Corporation

Official(s) and/or principal investigator(s):
Edward Benzel, MD, Principal Investigator, Affiliation: The Cleveland Clinic Spine Institute

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.

Official title: Randomized Controlled Trial of DuraGen Plus® Adhesion Barrier Matrix to Minimize Adhesions Following Lumbar Discectomy

Study design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Radiological, pain, and functional outcome assessments

Secondary outcome: Radiological, pain, and functional outcome assessments

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Ronderos Neurosurgery Center, Providence Hospital, Mobile, Alabama 36608, United States; Recruiting
Rachel Johnson, Study Coord., Phone: 251-639-2921
Juan Ronderos, MD, Principal Investigator

Spine Source, Beverly Hills, California 90212, United States; Recruiting
Liz Homsher, CCRC, Phone: 310-385-8015
John Regan, MD, Principal Investigator

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States; Recruiting
Beth Habelow, Study Coord., Phone: 310-423-9211
Khawar Siddique, MD, Principal Investigator

Mission Hospital, Mission Viejo, California 92691, United States; Active, not recruiting

Spine Institute, Santa Monica, California 90404, United States; Recruiting
Carmen Battles, Phone: 310-828-7757
Hyun Bae, MD, Principal Investigator

Southern California Orthopedic Institute, Van Nuys, California 91405, United States; Recruiting
Dealie Park, Study Coord., Phone: 818-901-6600
Todd Moldawer, MD, Principal Investigator

University of California, San Diego, San Diego, California 92103, United States; Recruiting
Denise Harris, CRC, Phone: 619-543-7456
Yu-Po Lee, MD, Principal Investigator

Greenwich Neurosurgery/Greenwich Hospital, Greenwich, Connecticut 06830, United States; Recruiting
Lauren Stabile, Study Coord., Phone: 203-661-3333
Zoher Ghogawala, MD, Principal Investigator

University of Miami, Miami, Florida 33136, United States; Active, not recruiting

The Back Center, Melbourne, Florida 32901, United States; Recruiting
Marianne Bridges, RN, Phone: 321-308-3204
Julio Torres, RMA, CRC, Phone: 321-693-8832
Devin Datta, MD, Principal Investigator
Mitchell Supler, MD, Sub-Investigator

University of South Florida, Tampa, Florida 33606, United States; Recruiting
Deborah Scott, BA, CCRC, Phone: 813-259-0616
Fernando Vale, MD, Principal Investigator

Orthopaedic Specialties Spine Center, Clearwater, Florida 33756, United States; Recruiting
Aileen Bair, RN, BSN, Phone: 727-449-2599
J. Byron Davidson, DO, Principal Investigator
Michael Piazza, MD, Sub-Investigator

Tallahassee Neurological Clinic, Tallahassee, Florida 32308, United States; Recruiting
Kathryn Dilks, RN, Study Coord., Phone: 850-877-5115
Mark Cuffe, MD, Principal Investigator

Southeastern Orthopedic Center, Savannah, Georgia 31405, United States; Recruiting
Kelly Wiggins, RN, Study Coord., Phone: 912-644-5300
James Dewberry, MD, Principal Investigator

Chicago Institute of Neurosurgery and Neuroresearch, Chicago, Illinois 60640, United States; Recruiting
Michelle Catalano, Study Coord., Phone: 773-250-0500
Noam Stadlan, MD, Principal Investigator

Northwestern University, Chicago, Illinois 60611, United States; Recruiting
Narina Simonian, Study Coord., Phone: 312-695-4299
John Liu, MD, Principal Investigator

OSF Saint Francis Medical Center, Peoria, Illinois 61637, United States; Recruiting
Cynthia Betz, Study Coord., Phone: 309-676-0766
Daniel Fassett, MD, Principal Investigator

Bluegrass Orthopedics, Lexington, Kentucky 40509, United States; Recruiting
Elaine Wilhite, MS, Coord., Phone: 859-422-4552
Harry Lockstadt, MD, Principal Investigator

Interactive Neuroscience Center, Shreveport, Louisiana 71119, United States; Recruiting
Darlene Hall, Phone: 318-798-4330
Ravish Patwardhan, MD, Principal Investigator

Johns Hopkins Hospital, Baltimore, Maryland 21287, United States; Recruiting
Barbara Levit, Study Coord., Phone: 410-502-2383
Timothy Witham, MD, Principal Investigator

Columbia Orthopedic Group, Columbia, Missouri 65205, United States; Recruiting
James Ronan, Study Coord., Phone: 573-815-6088
Jeffrey Parker, MD, Principal Investigator
Randal Trecha, MD, Sub-Investigator
Thomas Highland, MD, Sub-Investigator

Montana Neuroscience Institute Foundation, Missoula, Montana 59802, United States; Recruiting
Julie Larkin, Study Coord, Phone: 406-329-2664
Kenneth Brewington, MD, Principal Investigator

William S. Muir, MD, PC, Las Vegas, Nevada 89169, United States; Recruiting
Sheila Moore, Study Coord., Phone: 702-401-3102
William S Muir, MD, Principal Investigator

University of Medicine and Dentistry of New Jersey, New Brunswick, New Jersey 08901, United States; Recruiting
Marie Macor, Phone: 732-235-7756
Michael Nosko, MD, PhD, Principal Investigator

The Cleveland Clinic Spine Institute, Cleveland, Ohio 44195, United States; Recruiting
Diane Fabec, RN, Phone: 216-445-7744
Edward Benzel, MD, Principal Investigator

University of Cincinnati Medical Center / Mayfield Clinic, Cincinnati, Ohio 45267, United States; Recruiting
Carolyn Koenig, RN, MS, Phone: 513-558-3518
Charles Kuntz, MD, Principal Investigator

Central Ohio Neurological Surgery, Westerville, Ohio 43081, United States; Recruiting
Pamela Moore, RN, Study Coord., Phone: 614-975-9370
William Zerick, MD, Principal Investigator

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting
Joanna Lopinto, RN, Phone: 215-615-4590
M. Sean Grady, MD, Principal Investigator

Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States; Recruiting
Deborah Hoffman, RN, CCRC, Phone: 717-531-0003, Ext: 283063
G. Timothy Reiter, MD, Principal Investigator

Princeton Brain and Spine Care, Langhorne, Pennsylvania 19047, United States; Active, not recruiting

Roger Williams Hospital, Providence, Rhode Island 02908, United States; Active, not recruiting

Texas Back Institute, Plano, Texas 75093, United States; Recruiting
SpineMark Clinical Research Organization at TBI, LP Study Coordinator, Phone: 972-403-5544
W. Dan Bradley, MD, Principal Investigator

Virginia Commonwealth University Health System, Richmond, Virginia 23298, United States; Recruiting
Patricia Leach, RN, Phone: 804-828-9165
Bruce Mathern, MD, Principal Investigator

University of Virginia, Charlottesville, Virginia 22903, United States; Recruiting
Johanna Loomba, Study Coord., Phone: 434-924-8129
Yuliya Havaleshko
Jason Sheehan, MD, PhD, Principal Investigator

Swedish Neuroscience Institute, Seattle, Washington 98122, United States; Recruiting
Megan Alexander, PA-C, Study Coord., Phone: 206-320-4355
John Hsiang, MD, Principal Investigator

Orthopedics Intl., Seattle, Washington 98122, United States; Recruiting
Eileen Uson, Study Coord., Phone: 206-302-0702
Reginald Knight, MD, Principal Investigator

Starting date: October 2006
Last updated: September 1, 2009