Evidence based objective performance criteria for evaluation of hip and knee replacement devices and technologies.
Marc J NieuwenhuijsePer-Henrik RandsborgJensen H HydeWenna XiPatricia D FranklinLimin SunXinyan ZhengSamprit BanerjeeJialin MaoSuvekshya AryalPriscilla ChanAmanda C ChenAlexander Y LiebeskindPablo BonangelinoPaul VoorhorstLaura Elisabeth GresslerVincent J DevlinRaquel PeatDanica Marinac-DabicElizabeth PaxtonArt SedrakyanPublished in: International journal of surgery (London, England) (2023)
This study is the first to construct 2-year OPC for safety and effectiveness of THR and TKR based on US real-world data. Based on these OPC, potential benchmarks for (single-arm study) evaluation of new device innovations are suggested for regulated and safe introduction to the (commercial) market.