Evidence on the safety and efficacy of intramedullary distraction for upper limb lengthening is inadequate in quantity and quality. But because this is a rare condition with limited alternative treatments, the procedure can be considered as long as special arrangements for clinical governance, consent, and audit or research are in place. Find out what special arrangements mean on the NICE interventional procedures guidance page.
Clinicians wanting to use intramedullary distraction for upper limb lengthening should:
Inform the clinical governance leads in their healthcare organisation.
Give people (and their families and carers as appropriate) clear written information to support shared decision making, including NICE's information for the public.
Make sure that people (and their families and carers as appropriate) understand the procedure's safety and efficacy, and any uncertainties about these.
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 procedures 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:
Make sure systems are in place that support clinicians to collect and report data on outcomes and safety for everyone having this procedure.
Regularly review data on outcomes and safety for this procedure.
This technically challenging procedure should only be done in specialist centres by surgeons with specific training and experience in upper limb lengthening techniques, using a multidisciplinary approach.
Report any problems with a medical device using the Medicines and Healthcare products Regulatory Agency's Yellow Card Scheme.
Further research, which could be registry data, should report details of patient selection, device selection, technique used, procedural outcomes, long-term outcomes including quality of life, the need for repeat interventions or surgery, and complication rates.