5A* ODEP rating for the cement-free A2® short stem

At ARTIQO there is reason to be happy these days. The British Orthopedic Data Evaluation Panel (ODEP) has awarded the cement-free A2® short stem (types B and G) a 5A* rating. This highest possible rating after 5 years of service is based on a validated database and is awarded by an independent evaluation committee according to defined criteria. This is intended to support users in comparing and selecting safe implants.

Sophie Koerner, an employee in ARTIQO quality management, explains what the 5A* rating says: “The number in the rating indicates the follow-up period for which data is available and has been evaluated. The cement-free A2® short stem is currently 5 years old. The A* rating is the highest possible ODEP rating category. Very strict criteria are applied for them: For a 5A* rating, a follow-up group with at least 250 patients is required that shows a maximum revision rate of ≤3.5%.” With the A2® short stem, the revision rate after five years is 2.3 % [1.9%;2.7%] with a follow-up group of 260 patients (source: EPRD annual report 2022).

Independent reviews for quality standards and greater comparability

“The purpose of such a rating is to prove the safety of our implants,” says Mario Frank, member of the ARTIQO management, describing the importance of the quality certificate. “For this we need independent bodies like the British ODEP. You can confirm that our implants meet the highest standards. The easy-to-understand ODEP ratings ensure good comparability of implants. They have established themselves as an international benchmark.” The latter in particular is playing an increasingly important role for the ARTIQO company, as the A2® short stem is also attracting increasing interest in other European countries.

Validated database

Sophie Koerner explains the data basis on which the cement-free A2® short stem met the high requirements of the ODEP rating 5A*: “ODEP requires validated data. At the time of submission, these were data from the publicly available EPRD annual report 2022 and from the EPRD detailed report, which is reserved for us as a manufacturer.” Data from prospective clinical studies can also be submitted. For implant systems, the results are differentiated according to variants. “In our case, these were stem types B and G. If parts of the system do not meet the tracking requirements or the results are different, this is taken into account in the rating. In the case of the A2® short stem, both stem types (B and G) meet the requirements of the 5A* rating, so that this could be issued for the cement-free A2® stem without any restrictions.”

The ODEP

The Orthopedic Data Evaluation Panel (ODEP) is an independent UK expert panel that carries out objective and systematic assessments of the performance of implants. The assessment is based on validated literature, study and register data using a series of benchmarks (see table). The goal is to promote evidence-based implant selection. This no longer only applies to the united kingdom. The ODEP ratings are also attracting more and more attention in other European countries.

The latest ODEP ratings can be found here: odep.org.uk