Spine Institute of Arizona

CLINICAL TRIAL FOR THE TREATMENT OF A COMMON BACK CONDITION

DIAM™ Spinal Stabilization System Approved for Clinical Trial in The United States

For approximately half the population over 40, degenerative disc disease can cause several symptoms, including back pain. This year over 12 million people will undergo one or more non-operative therapies to alleviate their back pain and restore health to their spine. The DIAM™ System offers patients an alternative treatment option for back pain, by implanting a small device made primarily of silicon and polyester, through a small incision in the back between two spinous processes. The spinous processes are the parts of the spinal bones that one can feel protruding from the back of the spinal column; therefore the device is implanted without exposing the spinal nerves or entering the spinal canal.

Over 15,000 patients have had the DIAM™ implanted in Europe. The US clinical trial will be used to help support an application to the U.S. Food and Drug Administration (FDA), that could allow the approved future non-trial use of the device in the United States.

The randomized study will compare the DIAM™ System to non-surgical, conservative treatment. Patients enrolled in the study will be randomly assigned to receive either the DIAM™ System or traditional non-surgical treatment that involves medication, physical therapy, patient education, and spinal injections. Information about the DIAM™ System clinical trial can be found at www.back.com/clinicaltrial.

Patients must meet specific inclusion and exclusion criteria to be considered for this study. A few of these criteria are that patients must:
• Be between 18-70 years of age
• Have degenerative disc disease between L2-L5
• Not be pregnant or planning a pregnancy during the study
• Be willing and able to participate in either of the randomized treatments, and be evaluated at regular intervals for twenty-four months following the randomization.

All potential candidates are also subject to other non-listed clinical trial criteria.

We are excited that Dr. Dohring and Dr. Cluck are currently the only Arizona spine surgeons participating in this clinical trial. For more information or to refer a potential patient for the trial, please contact Donna or Andrea at the Spine Institute of Arizona, 602-953-9500.

Caution: Investigational device, limited by Federal (or United States) law to investigational use.