Valid from 18 March 2024
Following the introduction of ODEP ratings for smaller volume implants such as elbow replacements, a group was set up in 2021 to explore the possibility providing ODEP ratings for hand and wrist implants. The devices available for arthroplasty in the hand and wrist cover a variety of implant types and design philosophies. After setting up the ODEP process to assess total wrist arthroplasty the next arthroplasty to be considered was total base of thumb arthroplasty (first CMC joint) which is being performed in increasing volumes. A literature review of best available evidence was used to formulate the assessment criteria.
In early 2024 manufactures were invited to submit data ‘dummy run’ process to test how the new assessment criteria (shown above) worked in practice. The submissions were assessed by the hand and wrist panel and recommendations made in accordance with standard ODEP practice and in relation to the assessment criteria.
For implants that have more than one type of articulation available it was made clear that these need to be assessed separately and they will be issued with a separate ODEP rating based on survival data that specifically relates to that articulation. For example if a manufacture supplied unipolar and a bipolar articulation each would receive its own ODEP rating if sufficient data were supplied for each. If a bearing type lacks sufficient data it will not be awarded an ODEP rating.
Similarly, implants with significant differences in cup design, such as hemispherical or conical, will be rated separately.
Following this successful ‘dummy run’ manufactures are invited to submit data for the first official round of total wrist arthroplasty assessment later in 2024. Going forward there will be regular opportunities to submit data for assessment by the panel. The dates of these will be advertised through the ODEP website.
The panel recognise that this process is new to base of thumb arthroplasty and the assessment criteria will be regularly reviewed to ensure that the ratings awarded remain robust.