1.1 Current evidence on the safety and efficacy of sinus tarsi implant insertion for mobile flatfoot is inadequate in quality and quantity. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2 Clinicians wishing to undertake sinus tarsi implant insertion for mobile flatfoot should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that patients and/or their parents/carers understand the uncertainty about the procedure's safety and efficacy in relation to symptom relief, quality of life, and long-term outcomes; that the success of the procedure may be dependent on the aetiology of their flatfoot; that there may be a need for adjunctive or subsequent procedures; and that the implant may need to be removed. Patients and parents or carers should be provided with clear written information. In addition, the use of NICE's information for patients ('Understanding NICE guidance') is recommended.
Audit and review clinical outcomes of all patients having sinus tarsi implant insertion for mobile flatfoot (see section 3.1).
1.3 Sinus tarsi implant insertion is not appropriate for most children with mobile flatfoot. The procedure may be used in selected children with persistent mobile flatfoot due to neuromuscular disorder, skeletal dysplasia or systemic ligamentous laxity, whose treatment is supervised by a multidisciplinary team. The procedure may be indicated rarely in highly selected adult patients.
1.4 NICE encourages further research into sinus tarsi implant insertion for mobile flatfoot. Research studies should define patient selection criteria, address uncertainties about using the procedure in children and in adults, include descriptions of adjunctive procedures, and provide long-term outcome data. Studies comparing outcomes of the procedure with the natural history of mobile flatfoot would be useful. NICE may review the procedure upon publication of further evidence.