Direct skeletal fixation of limb prostheses using an intraosseous transcutaneous implant

NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 9 sources, which was discussed by the committee. The evidence included 1 HTA, 3 systematic reviews, 2 retrospective cohort studies, 2 retrospective reviews, and 1 cross-sectional observational study. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.

The professional experts, patient representatives and the committee considered the key efficacy outcomes to be: improvement in mobility, reduction in falls and quality of life.

The professional experts, patient representatives and the committee considered the key safety outcomes to be: pain, infection, fractures, implant failure, osteomyelitis, need for device removal and potential limb shortening.

Seventeen commentaries from people who have had this procedure were discussed by the committee. Submissions provided by 1 patient organisation representing people who have had this procedure were discussed by the committee.

Most of the evidence reviewed was from people who had above-knee amputations.

This procedure could provide significant benefit in some people who are unable to tolerate a conventional prosthesis and could provide a dramatic improvement in quality of life.

This procedure may be paired with a microprocessor prosthetic.

People being considered for the procedure should be informed of the significant risk of serious complications including the need for repeated operations, removals and infections.

Long-term outcomes, particularly in young people, need to be carefully monitored.

Appropriate post-operative care including management of soft tissues and long‑term rehabilitation is important.

Patient commentary was mixed and included examples of both profoundly positive and negative experiences, but all people responding to the survey said they would recommend this procedure to others in the same situation.

The patient experts explained how the procedure could be life-changing for some people but there is always a risk of complications. One patient expert said that infection can be extremely serious and lead to further loss of bone. Both experts agreed that patient selection was a vital factor in deciding who has the procedure, but that age should not predetermine whether someone is able to adhere to rehabilitation or recovery.

There is more than one device, and the technology and procedure are evolving.

The committee were informed that it is more difficult to secure an implant in a tibia than a femur, because of the shape of the bone.