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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Validity and generalisability of the studies

    • CE-marked devices (HemiCAP, UniCAP, Episealer, and BioPoly) were used in all studies.

    • It is not clear which implant produces the most favourable outcomes. There was some evidence of high revision rates from the Australian Orthopaedic Association National Joint Replacement Registry for the HemiCAP implant. However, Christensen (2021) showed substantially lower revision rates. In the 1 comparative study, BioPoly was found to be a statistically significant predictor of revision (vs. HemiCAP), though this analysis may have been confounded by trauma in several people with BioPoly. Evidence from Ryd (2021) showed that the revision rate of Episealer may be relatively low.

    • Several publications noted that improper patient and device selection may have resulted in higher revision rates.

    • The Episealer implant is custom-made based on an MRI scan of the defect site. The BioPoly and HemiCAP/UniCAP implants are selected from catalogues of multiple sizes to closely fit the defect site.

    • Studies were conducted in Australia, Belgium. Denmark, Germany, Ireland, Sweden, The Netherlands, Turkey, UK. Therefore, it is likely that the evidence is generalisable to UK clinical practice.

    • Studies did not report adjustment for multiple comparisons. Testing many hypotheses without adjustment for multiple comparisons increases the likelihood of finding a statistically significant difference between sets of data that are only different due to chance.

    • Studies mainly had an observational or quasi-experimental design. There were no randomised experimental studies identified. As this procedure is aimed at people for whom biological treatment or arthroplasty may be unsuitable, these study designs are appropriate.

    • Primary outcomes were typically assessed at 2 years after surgery. The longest follow up was 12 years.