LA JOLLA, Calif.–(BUSINESS WIRE)–Robert Eastlack, M.D., of Scripps Clinic and the Scripps Clinical Research Center announced recently that he is enrolling patients in a new clinical study pertaining to back pain caused by compression fractures of the spine, a painful medical condition that primarily affects patients with osteoporosis.
The OsseoFix Spinal Fracture Reduction System clinical study tests an innovative treatment utilizing an implant made of titanium alloy and pure titanium that forms a cage-like structure inside the vertebral body after implantation. After deployment vertebral bone is located both inside and outside of the implant. The device is placed and deployed in a controlled manner so that it can add structure to a vertebral body that has been weakened due to a compression fracture. Bone cement is added to the deployed implant to strengthen the construct. The combination of bone, cement and the implant mimics the support system naturally present inside the vertebral body. The device is implanted in a minimally invasive surgical procedure.
“Due to the cement’s interdigitation with the bone and the stability provided by the titanium implant, we can use much less bone cement than what we would be required to use for the current standards of care,” said Dr. Eastlack. “This is important in that it helps to reduce the risk of cement-related complications. The implant assists in preventing the collapse of the vertebra during the surgery and during the period when the cement hardens. Therefore the highest possible stability of the vertebra is allowed. The surgical procedure only takes approximately 30 minutes per vertebra, which is extremely important for older patients, because the stress on the body can be reduced significantly by reducing surgery time.”
The OsseoFix is not commercially available for sale in the U.S. The OsseoFix has been approved for sale in Europe, and has been used in over 900 patients in Europe.
The OsseoFix study is a prospective, multi-center clinical study that is being conducted to support the 510(k) clearance for the OsseoFix Spinal Fracture Reduction System. This study will follow study participants for at least 12 months and will be conducted in up to 15 centers across the U.S.
For more information regarding this study please call: 800-680-5838