التفاصيل البيبلوغرافية
| العنوان: |
Arthroplasty registries: a valuable tool to orthopaedic surgeons, manufacturers, patients and regulators? |
| المؤلفون: |
Gerbers, Jasper G., Nelissen, Rob GHH. |
| المصدر: |
Orthopaedics & Trauma; Jun2024, Vol. 38 Issue 3, p118-123, 6p |
| مصطلحات موضوعية: |
PRODUCT safety, PATIENTS, PATIENT safety, ARTHROPLASTY, MEDICAL implant registries, ORTHOPEDICS, MANUFACTURING industries, REOPERATION, MEDICAL equipment reliability, HEALTH outcome assessment, GOVERNMENT regulation, PATIENT aftercare |
| مستخلص: |
Historically, orthopaedic implants required little clinical evidence before market introduction, either in the USA or the European Union (EU). There have been major incidents, with faulty designs or manufacturing techniques resulting in patient harm. The new EU Medical Device Regulations (MDR) have significantly changed the requirements around the introduction to the market of new medical devices in the EU. Initiatives like CORE-MD are founded to improve this process. EUDAMED will provide a mandatory European implant safety register. Real-world data, such as implant registries, have a major role to play in the continuous monitoring of implants, but this depends on them having high completeness (>95%) as well as coverage. Registries can also be used for post-market surveillance. Although implant registries use endpoints such as revision, as well as patient-reported outcomes, long-term follow-up is still needed to detect mediocre implants. For new designs, this often takes too long and potentially exposes patients to mediocre implants. This can be prevented by using more accurate, highly predictive methods at early follow-up (at 1 year), such as implant migration studies. Furthermore, registry-based or nested randomized controlled trials can be used to evaluate new implant designs and surgical techniques. Monitoring implants through registries remains vital in order to detect early or late unexpected failures related to the implant, surgical technique or indication, enhancing both implant development as well as patient safety. [ABSTRACT FROM AUTHOR] |
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