Synthetic cartilage implant insertion for first metatarsophalangeal joint osteoarthritis (hallux rigidus)
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3 Committee considerations
The evidence
3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 15 sources, which was discussed by the committee. The evidence included 1 randomised controlled trial (described in 2 papers), 4 non-randomised comparative studies, 7 case series, 1 case report and a review of adverse events from the US Food and Drug Administration Manufacturer and User Facility Device Experience database. It is presented in the summary of key evidence section in the interventional procedures overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: pain, mobility, quality of life and range of movement.
3.3 The professional experts and the committee considered the key safety outcomes to be: pain, infection and need for device removal.
3.4 Patient commentary was sought but none was received.
Committee comments
3.5 The committee was informed that the procedure should not be used in people with inflammatory arthritis or diabetic peripheral neuropathy.
Tom Clutton-Brock
Chair, interventional procedures advisory committee
January 2021
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