Guidance
1 Recommendations
1 Recommendations
1.1 Evidence on the safety and efficacy of intramedullary distraction for lower limb lengthening is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. Find out what special arrangements mean on the NICE interventional procedures guidance page. This guidance is not intended to cover this procedure for bilateral lower limb lengthening for people with short stature.
1.2 Clinicians wanting to do intramedullary distraction for lower limb lengthening should:
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Inform the clinical governance leads in their healthcare organisation.
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Give patients (and their families and carers as appropriate) clear information to support shared decision making, including NICE's information for the public.
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Ensure that patients (and their families and carers as appropriate) understand the procedure's safety and efficacy, and any uncertainties about these.
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Audit and review clinical outcomes of all patients 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).
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Discuss the outcomes of the procedure during their annual appraisal to reflect, learn and improve.
1.3 Healthcare organisations should:
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Ensure systems are in place that support clinicians to collect and report data on outcomes and safety for every patient having this procedure.
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Regularly review data on outcomes and safety for this procedure.
1.4 Patient selection should be done by a multidisciplinary team that ideally includes physiotherapy and psychological support.
1.5 This technically challenging procedure should only be done in specialist centres by surgeons with training and specific experience in limb lengthening techniques.
1.6 Report any problems with a medical device using the Medicines and Healthcare products Regulatory Agency's Yellow Card Scheme.
1.7 Further research should report details of patient selection, device selection, procedural outcomes, long-term outcomes including quality of life, the need for repeat interventions or surgery, and complication rates. This research could be registry data.