DIAM™ Spinal Stabilization System Clinical Trial Underway
Take Action:
To find out if you may be a
candidate for this clinical trial,
call the site nearest you for information.Spinal surgeons around the country are now enrolling candidates for a clinical trial to study the DIAM™ Spinal Stabilization System. This clinical trial will study the safety and effectiveness of the device for treatment of degenerative disc disease (DDD) at a single level between L2-L5. Symptoms of degenerative disc disease are often described as persistent low back pain, sometimes accompanied by leg pain.
This is a randomized clinical trial comparing the DIAM™ Device to non-surgical, conservative treatment. Patients enrolled in the study will be randomly assigned to receive either the investigational DIAM™ Device or non-surgical treatment that involves medication, physical therapy, patient education and spinal injections. Patients enrolled in the study must be evaluated by their surgeon at regular intervals.
About the DIAM™ Spinal Stabilization System
Through a small incision, the DIAM™ System implant is inserted between two spinous processes to stabilize the spine. The spinous process is the portion of the vertebrae that protrudes from the back of the spinal column. They create the "bumps" that you can feel along the middle of your back.
The core of the DIAM™ System implant is made of silicone. The outer mesh and tether are made of polyethylene terephthalate (polyester). The crimp is titanium. The device is available in a variety of sizes to allow the surgeon to accommodate the patient's individual anatomy.
How Can I Find Out If I Am A Potential Candidate For This Study?
Only a clinical investigator can determine if you are eligible to participate in this study. At a minimum, you must meet the following key criteria:
- Low back pain defined as persistent back pain, with or without radicular (leg) pain, of less than one year duration (current episode)
- Diagnoses of degenerative disc disease at single level between L2-L5
- Between 18-70 years of age
- At least 6 weeks, but no more than 6 months, of non-operative treatment prior to enrollment
- Not pregnant or planning a pregnancy during the study
- Willing and able to participate in either of the randomized treatments for the duration of the study follow up period.
All potential candidates are subject to the above and additional non-listed clinical trial criteria. To find out if you are a candidate for this clinical trial, please call the site nearest you for information.
Clinical Study Sites (Check back for updates.)
Arizona
Principle Investigator - Edward Dohring, MD
Study Coordinator - Andrea Gasten
Scottsdale, AZ
P: 602-953-9500
California
Principal Investigator: Wayne Cheng, MD
Study Coordinator: Elisabeth Clarke
Loma Linda, CA
Ph: (909) 835-1779
Principal Investigator - Sylvain Palmer, MD
Study Coordinator - Gladys Andreas
Mission Viejo, CA
P: 949-364-1400 ext. 7519
Principal Investigator - Carl Lauryssen, MD
Study Coordinator – Lacey Feldman
Beverly Hills, CA
P: 310-855-0751 ext 2109
Principal Investigator: George Rappard, MD
Study Coordinator: Nancy Rappard
Los Angeles, CA
Ph: (323) 857-5300
Florida
Principal Investigator: James B. Billys, MD
Study Coordinator: Debbi Clabeaux RN, CCRC
Temple Terrace, FL
Ph: (813)-978-9700 x 6766
Principal Investigator - Christopher Rumana, MD
Study Coordinator - Lutheria Hollis, CCRC
Tallahassee, FL.
P: 850-201-2350
Indiana
Principal Investigator: Kevin A. Rahn, MD
Sub-Investigator: Robert Shugart, MD
Sub-Investigator: Michael Arata, MD
Study Coordinator: Kary Stout, CCRC
Fort Wayne, IN
Ph: (260) 436-6589 ext. 4278
Principal Investigator: David D. Schwartz, MD
Study Coordinator: Kim Fitzpatrick
Indianapolis, IN
Ph: (317) 802-2000
Principal Investigator -Rick Sasso, MD
Study Coordinator - Sheetal Vinayek, M.Sc, CCRP
Carmel, IN.
P: 317-715-5897
Kansas
Principal Investigator: Alex Bailey, MD
Study Coordinator: Edwina Littlejohn, PA
Overland Park, KS
Ph: (913) 387-2800
Principal Investigator: Camden Whitaker, MD
Study Coordinator: Linda Brooks
Wichita, KS
Ph: (316) 650-0889
Massachusetts
Principal Investigator - Richard M. Ozuna, MD
Study Coordinator - Jocelis Uribe
Peabody, MA
P: (978)-818-6459
Michigan
Principal Investigator – Hazem Eltahawy, MD
Study Coordinator – Carmen Hughes, BSN, CCRA, CCRP
Detroit, MI
P: (313) 966-7218
Missouri
Principal Investigator: Matthew Gornet, MD
Study Coordinator: Francine Schranck
Chesterfield, MO
Ph: (314) 336-2555
Ohio
Principal Investigator: Jamal Taha, MD
Study Coordinator: Lynne Bradford, RN BSN
Kettering, OH
Ph: (937) 395-8422
Oregon
Principal Investigator -Scott H. Kitchel, MD
Study Coordinator - Shawn Potts
Eugene, OR
P: 541-284-0530
Pennsylvania
Principal Investigator: Perry Argires, MD
Study Coordinator: Connie Martin, LPN
Lancaster, PA
Ph: (717) 358-0815
Tennessee
Principal Investigator: Douglas Linville, MD
Study Coordinator: Crystal Rapp
Memphis, TN
Ph: (901) 767-9500
Texas
Principal Investigator: Juan Bartolomei, MD
Study Coordinator: Nelda Danes
Southlake, TX
Ph: (817) 442-9300
Principal Investigator: Luis Mignucci, MD
Study Coordinator: Joyce Govrin, BS
Plano, TX
Ph: (972) 378-6908
Utah
Principal Investigator: Stephen Hansen, MD
Study Coordinator: Michael R. Braun
Sandy, UT
Ph: (801) 352-9228
District of Columbia
Principal Investigator: Warren Yu, MD
Study Coordinator: Stacy Tam
Washington, DC
Ph: (207)-742-3309
Caution: Investigational device, limited by Federal (or United States) law to investigational use.
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