ORLANDO, Fla. — A Food and Drug Administration early feasibility study is expected to begin next year to test osseointegrated implants on humans, according to the presenter of the Keynote Address here at the O&P World Congress.
Roy Bloebaum, PhD, research professor at the University of Utah School of Medicine and co-director of the Department of Veterans Affairs Bone and Joint Research Lab in Salt Lake City, said a percutaneous, osseointegrated implant can mitigate socket complications, such as pain, discomfort, skin breakdown, pressure sores, phantom pain and muscle weakness, as well as improve mobility, comfort and the ability to quickly don and doff a prostheses.
Bloebaum and his colleagues have successfully implanted osseointegrated devices in sheep models, and they except to begin implanting the devices on human participants in April 2014.
“We want to inhibit periprosthetic infections, and we want to get successful load bearing,” he said.
The study, collaboration between the University of Utah, Walter Reed National Military Medical Center and Brooke Army Medical Center, will include 10 transfemoral amputee participants. The evaluation process will include psychological and social prescreening tests and pre-implant and post-implant assessments, as well as a two-stage implementation procedure. Patients will then undergo follow-up testing for a minimum of 12 months, and two independent review boards will monitor the study.
Although osseointegration technology has had success in Europe, Bloebaum said it will be at least 10 years before long-term outcomes can be measured in the United States.
“You should encourage patients that there are still risks,” Bloebaum said. “We are a decade out before we truly know the effects of all of this.”
For more information:
Bloebaum R. Keynote address. Presented at: O&P World Congress. Sept. 18-21, 2013. Orlando, Fla.
Disclosure: Bloebaum has no relevant financial disclosures. This research is funded by grants from The Telemedicine & Advanced Technology Research Center, Peer Reviewed Medical Research Program, the National Institutes of Health, Walter Reed Army Medical Center, the Department of Veterans Affairs, DJO Surgical and the University of Utah.