OrthoIndy, a leader in advanced orthopedic care, has announced that the health company is the first orthopedic practice worldwide to treat patients in a new clinical trial evaluating an innovative spinal fusion implant for degenerative spine conditions. The Phase I/II OASIS trial is assessing the safety and effectiveness of OsteoAdapt SP, an investigational device developed by Theradaptive, Inc., to address challenges associated with traditional bone grafts and artificial implants in spinal fusion, a procedure that stabilizes and connects bones in the spine.
Unlike traditional bone grafts, the OsteoAdapt SP implant is made from synthetic material and contains a specially engineered protein designed to encourage bone growth. The implant eliminates the risk of disease transmission that can be associated with donor bone grafts. It may also reduce or even prevent chronic pain some patients experience with bone grafts recovered from their own bodies.
Dr. David Schwartz, a spine surgeon at OrthoIndy Hospital, performed the first procedure in the trial, followed by fellow OrthoIndy spine surgeon Dr. M. Craig McMains, who recently performed the second procedure.
"OrthoIndy has a proud history of clinical research, including early work in recombinant BMP spinal fusion studies over 25 years ago," said Dr. Schwartz. "Theradaptive's technology represents a significant advancement in the application of these potent bone-forming proteins, and I'm honored to be a part of this important clinical study to help evaluate the potential to improve spinal fusion outcomes for my patients and others worldwide.”