ITAP Amputee Implant
The ITAP implant is currently only available as part of a pre-CE mark clinical study in the UK, i.e. "Exclusively for clinical investigations". This UK clinical study is intended for existing amputees with above knee amputations.
The ITAP implant is not CE marked or available commercially in any other country
Stanmore Implants developed the ITAP (Intraosseous Transcutaneous Amputation Prosthesis) osseointegration implant for amputees as an alternative, more physiological method for attaching prosthetic limbs to the body, which is intended to prevent the amputee from having to use a socket to attach the upper limb or lower limb prosthesis.
The ITAP amputee implant is osseointegrated, i.e. forms a direct interface between the implant and the bone, without intervening soft tissue. The ITAP protrudes out through the amputated limb and provides a secure attachment point for the prosthetic limb. This means that loads experienced during daily activities, such as walking, can be taken through the skeleton rather than through soft tissue.
The ITAP is intended to allow an amputee to attach and remove their prosthetic limb easily, quickly and repeatedly by using a safety device which is at the top of their prosthetic limb instead of a socket. The amputee has direct control of the prosthesis from their skeleton, bypassing the soft tissues of their amputation stump. The safety device is also intended to act like a ski binding which attaches the ski boot to the ski but releases when high loads are applied. In a similar way the ITAP safety device releases to prevent damage to the bone or implant such as during a fall.
The design of the ITAP implant draws on Stanmore Implants' extensive experience of creating osseointegrated orthopaedic implants such as patient specific Distal Femur endoprostheses which encourage bone integration for implant stability. The ITAP implant is unique as it is also designed and intended to encourage the soft tissues to grow onto and into the implant to help form a seal around it. The inspiration for the ITAP design came from deer antlers, which are an example of bone growing out through the skin and which can experience heavy loads. A study of deer antlers by Pendegrass et al. from UCL (2006), found that deer antler bone is porous under the skin which allows the soft tissues to grow into the holes and stabilise the soft tissue around the antler. Outside the skin the antlers are smoother with fewer holes to prevent the build-up of dirt and bacteria therefore helping reduce the risk of infection.
Despite massive improvements in the technology of prosthetic limbs, including advanced materials and sophisticated microprocessor control, the method of attaching prosthetic limbs to the body has essentially remained the same for hundreds of years. The ITAP amputee implant is intended to bring a new way of attaching a prosthetic limb giving better control and perception, without the problems associated with conventional sockets.
Results of the UK clinical study will be used to support a CE mark for the ITAP device, allowing it to be used by amputee patients throughout Europe.
Pendegrass CJ, Goodship AE, Price JS, Blunn GW. Nature's answer to breaching the skin barrier: an innovative development for amputees. J Anat. Jul;209(1):59-67.
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