Magazine article American Nurse Today

FDA Authorizes Use of Prosthesis for Rehabilitation of Above-the-Knee Amputations

Magazine article American Nurse Today

FDA Authorizes Use of Prosthesis for Rehabilitation of Above-the-Knee Amputations

Article excerpt

For Immediate Release

July 16, 2015


The U.S. Food and Drug Administration today authorized use of the first prosthesis marketed in the U.S. for adults who have amputations above the knee and who have rehabilitation problems with, or cannot use, a conventional socket prosthesis.

The Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) device instead uses fixtures and screws implanted into the patient's remaining thigh bone to connect an external prosthetic limb. A conventional leg prosthesis uses a specially-fitted cup-like shell called a socket that fits over the remaining portion of the patient's leg (the residual limb) to secure the device to the leg. Some patients may not have a long enough residual limb to properly fit a socket prosthesis or may have other conditions, such as scarring, pain, recurrent skin infections, or fluctuations in the shape of the residual limb that prevent them from being able to use a prosthesis with a socket.

"Prostheses can help people who have lost a leg due to trauma or cancer to regain mobility and to more easily participate in everyday activities," said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health. "The OPRA device may help those with above-the-knee amputations who have had problems with rehabilitation and have not been able to benefit from available socket prostheses."

The OPRA device is installed with two surgical procedures. In the first procedure, a cylinder-shaped fixture is implanted into the central canal of the remaining thigh bone. Approximately six months later, after tissue has grown to anchor the fixture and the skin tissue has healed, a second surgery is performed to implant a rod that attaches to the fixture from the previous surgery. This rod extends through the skin at the bottom of the patient's residual limb and connects to the prosthetic leg.

After the second surgery, the patient works with a trained physical therapist to gradually place weight on the OPRA device using a training prosthesis. Patients require about six months of training and rehabilitation after the second surgery, before being fitted with their own customized prosthesis by a trained prosthetist. …

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