Direct skeletal fixation of limb prostheses using an intraosseous transcutaneous implant can be used in the NHS while more evidence is generated. It can only be used with special arrangements for clinical governance, consent, and audit or research.
Healthcare professionals wanting to do direct skeletal fixation of limb prostheses using an intraosseous transcutaneous implant should:
Inform the clinical governance leads in their healthcare organisation.
Ensure that people (and their families and carers as appropriate) understand the procedure's safety and efficacy, and any uncertainties about these.
Take account of NICE's advice on shared decision making, including NICE's information for the public.
Audit and review clinical outcomes of everyone having the procedure. The main efficacy and safety outcomes identified in this guidance can be entered into NICE's interventional procedure outcomes audit tool (for use at local discretion).
Discuss the outcomes of the procedure during their annual appraisal to reflect, learn and improve.
Healthcare organisations should:
ensure systems are in place that support healthcare professionals to collect and report data on outcomes and safety for everyone having this procedure
regularly review data on outcomes and safety for this procedure.
Patient selection should be done by a multidisciplinary team with specific training and experience in the procedure and should include:
an orthopaedic surgeon experienced in amputation and device implantation
a plastic surgeon with experience in the necessary bone and soft tissue reconstruction
an anaesthetist, and
rehabilitation specialists including:
experts in prosthetics
occupational therapists, and
clinical psychologists.
The procedure should only be done in specialised centres by a multidisciplinary team with specific training and experience in the procedural techniques, and management and rehabilitation after the procedure.
Why the committee made these recommendations
The evidence for this procedure is limited in quality and mainly from observational studies. Short-term evidence suggests that people who have it after an amputation above the knee:
have improvements in quality of life and
are better able to carry out normal daily activities.
But there is evidence of serious complications such as fractures and infections. These can lead to additional treatments and surgery, which can have significant impact on a person's mental health.
It is unclear how well the procedure works in the long term or who would benefit most from having it. So, this procedure can only be used with special arrangements.