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.
3.5 The committee was informed that the procedure should not be used in people with inflammatory arthritis or diabetic peripheral neuropathy.
3.6 There was little evidence about the people for whom the procedure is most appropriate, particularly the stage of osteoarthritis at which it should be used.