Purpose: Arthroplasty registries gained increasing importance to the re-certification of orthopaedic implants according to the European Union (EU) Medical Device Regulation (MDR) adopted in 2017. Until recently, several European countries only had regional arthroplasty registries. Whether regional registries deliver data quality comparable with national registries remained unclear. Therefore, the purpose of this study was to validate the Austrian Tyrolean Hip Arthroplasty Registry (THAR) and to evaluate if this regional registry showed adequate adherence, completeness and correctness when compared with well-established national registries.
Methods: A consecutive series of 1100 primary total hip arthroplasties were identified from our institution's medical database. Patients were interviewed by phone and completed questionnaires after a mean follow-up period of 8.05 years and were asked if they had had revision surgeries. The data were compared to the corresponding dataset from the THAR.
Results: Adherence was 97.91% for primary total hip arthroplasty. Clinical follow-up identified 10 missing cases, resulting in adherence of 81.48% for revisions. Completeness of patient-reported outcome measurements was 78.55% before surgery and 84.45% 1 year after surgery. Correctness was 99.7% for demographic data, 99.54% for implant specifications, and 99.35% for mode of fixation.
Conclusion: The data of this study showed that regional arthroplasty registries can deliver data quality comparable with well-established national registries. The main reason for unrecorded revision cases and wrongly recoded implants was human error. Further digitalization with more automatic data submission may have the potential to reduce these failure rates in the future. Overall, the THAR represents a valid data source for re-certification of medical implants according to the EU's MDR.
Keywords: Adherence; Coverage; MDR; National; Regional; Revision.
© 2022. The Author(s).