Yesterday (July 16th, 2015), the U.S. Food and Drug Administration authorized a prosthesis designed for adults with above-the-knee amputations who have rehabilitation problems, or are unable to use a conventional prosthesis socket.
Manufactured by Integrum AB in Molndal, Sweden, the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) device uses a set of fixtures and screws that are attached to the user’s remaining thigh bone, that hold the prosthesis securely in place. This helps address many of the complications faced with above-the-knee amputations.
The press release describes the challenges with many above-the-knee prostheses. 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.”
According to Integrum’s website, “The implant components are surgically inserted into the bone of the amputation stump in two separate surgical sessions. The patient’s prosthesis is then attached to the outer part of the Abutment through the Axor™, a load control device that protects the implant from accidental loads in bending and rotational directions by means of a release mechanism.”
The claimed benefits of the OPRA Implant System?
– Increased range of motion
– Eliminates pressure, sores and pain caused by the socket
– Stable attachment
– Easy attachment and detachment
– Better walking ability
– Improved osseoperception (sensory feedback)
– Can be worn all day, every day
– Improved sitting comfort
– No socket adjustments required
– Suitable for short amputation stumps
Integrum’s website also states, “A bone anchored prosthesis will always fit, attach fast and correctly, and since it is not supported over the skin, all issues related to the sockets are eliminated. It allows wearing the prosthetic limb continuously with higher wearing comfort, endurance, and furthermore, only a bone-anchored prosthesis provides the liberating possibilities of free movement and osseoperception.”
According to the press release, following the second surgical session, “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.”
Integrum is the first company in the world with a bone anchored prosthesis to be approved by FDA.
Click here to read the FDA’s official press release
Images courtesy of Integrum website.
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