posted October 6, 2008
Memorial Health Care System is taking part in a national research study for a new investigational medical device focused on treating lumbar spine pain.
“The DIAM TM Spinal Stabilization System clinical research study is designed to study the potential pain relief gained in people suffering from low back pain and pain radiating in the legs,” said Scott Hodges, D.O., orthopedic spine surgeon at Memorial and lead investigator for this study. “The study compares the results of traditional spinal decompression to the same procedure using an interspinous spacer.”
The DIAM TM is a polyester and silicone device placed between two bones in an individual’s spine. The purpose of this clinical research study is to determine whether this new investigational device can reduce pain, increase function, and potentially improve the quality of life for those patients with lower back pain associated with spinal stenosis. Owned by Medtronic, Inc., the device has recently received approval from the U.S. Food and Drug Administration to begin clinical trials in the United States.
“Our vision is to integrate potential new technologies into the standard of care and improve outcomes for those who are suffering from debilitating back pain by partnering with our orthopedic spine surgeons in a collaborative effort,” said Debra Moore, interim president and CEO for Memorial Health Care System. “We are proud to be one of the exclusive locations offering this opportunity to people in our region.”
The study will take place in only 30 institutions nationally, with a target of 660 patients enrolled over a two year period. People diagnosed with single level degenerative lumbar stenosis who are interested in participating in the study will be screened for body weight, bone density, and previous non-operative therapies along with a list of other eligibility criteria. For more information about enrolling in the trial, please contact 423 495-CARE for a referral to a participating spine surgeon.
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