DIAM™ Spinal Stabilization System Clinical Trial Underway
For Patients with Degenerative Disc Disease
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
- 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.
Clinical Study Sites (Check back for updates.)
Caution: Investigational device, limited by Federal (or United States) law to investigational use.
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