1.1 Direct skeletal fixation of limb or digit prostheses using intraosseous transcutaneous implants may have potential advantages for some patients compared with conventional prosthetic sockets. However, current evidence on the safety and efficacy of this procedure is inadequate in quantity and there is a lack of long-term follow-up. Therefore the procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2 Clinicians wishing to undertake direct skeletal fixation of limb or digit prostheses using intraosseous transcutaneous implants should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that patients understand the uncertainty about the procedure's safety and efficacy, in particular with regard to the longer term, and provide them with clear written information. In addition, the use of the Institute's information for patients ('Understanding NICE guidance') is recommended.
Audit and review clinical outcomes of all patients having direct skeletal fixation of limb or digit prostheses using intraosseous transcutaneous implants (see section 3.1).
1.3 Patient selection should be carried out by a multidisciplinary team which should include a surgeon experienced in amputation and in the necessary bone and soft tissue reconstruction, and rehabilitation specialists, including experts in prosthetics and implant design.
1.4 Further publication of safety and efficacy outcomes will be useful. Clinicians are encouraged to collaborate in the collection and publication of data, particularly in relation to adverse events such as infection and long-term performance of the implants. The Institute may review the procedure upon publication of further evidence.