1.1 Current evidence on the safety and efficacy of intramedullary distraction for lower limb lengthening does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research. Although there is evidence of efficacy in lengthening the femur, evidence on its safety is inadequate. There is inadequate evidence on both efficacy and safety in lengthening the tibia.
1.2 Clinicians wishing to undertake intramedullary distraction for lower limb lengthening 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 its use for lengthening the tibia and its safety in use for lengthening the femur, and provide them with clear written information. In addition, use of the Institute's information for patients is recommended.
Audit and review clinical outcomes of all patients having intramedullary distraction techniques for lower limb lengthening (see section 3.1).
1.3 A number of devices are available for the procedure which may have different safety and efficacy profiles. The technology is continuing to evolve and clinicians should consider the choice of device on the basis of the most current available evidence.
1.4 Publication of safety and efficacy outcomes will be useful. The Institute may review the procedure upon publication of further evidence.