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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Synthetic cartilage implant insertion for first metatarsophalangeal joint osteoarthritis (hallux rigidus)

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    1 Draft recommendations

    1.1 For people with advanced disease for whom arthrodesis is indicated, evidence on the safety of synthetic cartilage implant insertion for first metatarsophalangeal joint osteoarthritis (hallux rigidus) shows no major safety concerns in the short term. But evidence on efficacy is limited in quantity and quality. Therefore, for these people, 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.

    1.2 For people without advanced disease and for whom arthrodesis is not indicated, evidence on the safety of synthetic cartilage implant insertion for hallux rigidus shows no major safety concerns in the short term. But evidence on efficacy is inadequate in quantity and quality. Therefore, for these people, this procedure should only be used in the context of research. Find out what only in research means on the NICE interventional procedures guidance page.

    1.3 Clinicians wanting to do synthetic cartilage implant insertion for hallux rigidus for people with advanced disease for whom arthrodesis is otherwise indicated 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 all people 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).

    • Enter details about all people having synthetic cartilage implant insertion for first metatarsophalangeal joint osteoarthritis (hallux rigidus) onto the BOFAS registry and review local clinical outcomes.

    • Discuss the outcomes of the procedure during their annual appraisal to reflect, learn and improve.

    1.4 Healthcare organisations should:

    • Ensure systems are in place that support clinicians to collect and report data on outcomes and safety for every person having this procedure.

    • Regularly review data on outcomes and safety for this procedure.

    1.5 Further research should include suitably powered randomised controlled trials. These should report details of patient selection, including stage of osteoarthritis, and patient-reported outcomes such as pain, mobility and quality of life, and long-term outcomes related to the implant.