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. 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. 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. 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.

中文翻译：

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蒂罗尔髋关节置换登记的外部验证

根据 2017 年通过的欧盟 (EU) 医疗器械法规 (MDR)，关节成形术注册对于骨科植入物的重新认证变得越来越重要。直到最近，一些欧洲国家只有区域性关节成形术注册。区域登记处是否提供与国家登记处相当的数据质量仍不清楚。因此，本研究的目的是验证奥地利蒂罗尔髋关节置换术登记处 (THAR)，并评估与完善的国家登记处相比，该区域登记处是否显示出足够的依从性、完整性和正确性。从我们机构的医学数据库中确定了一系列连续的 1100 例初次全髋关节置换术。平均随访 8 年后，通过电话采访患者并完成问卷调查。05 岁，被问到是否做过翻修手术。将数据与来自 THAR 的相应数据集进行比较。初次全髋关节置换术的依从率为 97.91%。临床随访发现10例缺失病例，修正依从率为81.48%。手术前患者报告结果测量的完整性为 78.55%，手术后 1 年为 84.45%。人口统计数据的正确率为 99.7%，种植体规格的正确率为 99.54%，固定方式的正确率为 99.35%。本研究的数据表明，区域关节成形术登记处可以提供与完善的国家登记处相媲美的数据质量。未记录的修订案例和错误重新编码的植入物的主要原因是人为错误。进一步的数字化和更自动的数据提交可能有可能在未来降低这些故障率。总体而言，THAR 代表了根据欧盟 MDR 重新认证医疗植入物的有效数据源。