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

Evidence-based recommendations on synthetic cartilage implant insertion for first metatarsophalangeal joint osteoarthritis (hallux rigidus). This involves replacing damaged cartilage with an artificial (synthetic) implant.

# Recommendations
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.
For all other people with hallux rigidus, 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.
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.
Enter details about all people having synthetic cartilage implant insertion for first metatarsophalangeal joint osteoarthritis (hallux rigidus) onto the British Orthopaedic Foot & Ankle Society (BOFAS) Registry and review local clinical outcomes.
Discuss the outcomes of the procedure during their annual appraisal to reflect, learn and improve.
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.
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.# The condition, current treatments and procedure

# The condition
Osteoarthritis is a common condition in which the surface of the joint becomes worn, and the adjacent bone thickens and forms osteophytes. It can affect the first metatarsophalangeal joint at the base of the big toe, which may become painful and stiff (hallux rigidus).

# Current treatments
Conservative treatments include exercise, physiotherapy, orthotics, analgesics, non-steroidal anti-inflammatory tablets and cream, and corticosteroid injections into the joint. Surgery may be needed if severe osteoarthritis of the first metatarsophalangeal joint does not respond to conservative treatments. If an osteophyte on the surface of the joint is the only problem, it can be trimmed (cheilectomy). The main surgical options for treating the whole joint are fusion (arthrodesis), osteotomy or joint replacement. Rarely, excision arthroplasty is offered.

# The procedure
Synthetic cartilage implant insertion for hallux rigidus is usually done under general or regional anaesthesia. A moulded cylindrical implant made of polyvinyl alcohol (a soft plastic-like substance) and saline is used with specifically designed single-use instruments. A small incision is made over the top of the big toe joint and a drill is used to remove enough bone to make an appropriately sized hole for the implant. The implant is placed into the hole in the bone and left slightly raised, providing a smooth and slippery surface in the area of the cartilage defect. Once the implant is in place, the incision is closed with sutures. Weight bearing can typically resume immediately after the procedure. The aim is to reduce pain and improve the toe's range of motion.