The term osseointegration (OI) refers to the establishment of a structural and functional connection between a biocompatible implant and living bone. Percutaneous osseointegrated implants have been developed and used to achieve direct skeletal attachment (DSA) of a prosthetic limb to the residual limb of a person with an amputation. Compared to currently available socket suspension techniques, direct skeletal attachment of a prosthetic limb through OI offers many potential advantages including improved mechanical transfer of motion, reduced risk of skin irritation, improved joint range-of-motion, and enhanced comfort. However, OI also presents the possibility of serious risks including infection and implant failure. Several different types of percutaneous OI implants are currently being used for the direct skeletal attachment of prosthetic limbs in the United States either under IRB approved research protocols or through FDA approved Humanitarian Use Device exemptions. This presentation will review recent advances in prosthetic socket suspension technology as well as describe the outcomes that have been demonstrated in an FDA early feasibility study which is the first human subjects study with this technology in the United States. The presentation will also cover the historical use of these devices in countries outside of the United States. Lastly, the presentation will touch on the future applications and potential of this technology for individuals with amputations.
- Discuss recent advances in prosthetic socket technology including the use of osseointegration for the direct skeletal attachment of prosthetic limbs.
- Appreciate the potential advantages and risks associated with use of percutaneous osseointegrated implants for the direct skeletal attachment of prosthetic limbs.
- Describe the outcomes of an FDA Early Feasibility Study using osseointegration for the direct skeletal attachment of prosthetic limbs in individuals with transfemoral level amputations.