Evidence based objective performance criteria for evaluation of hip and knee replacement devices and technologies.

Marc J Nieuwenhuijse, Per-Henrik Randsborg,Jensen H Hyde,Wenna Xi,Patricia Franklin, Limin Sun,Xinyan Zheng,Samprit Banerjee,Jialin Mao,Suvekshya Aryal,Priscilla Chan,Amanda Chen,Alexander Liebeskind, Pablo Bonangelino, Paul Voorhorst, Laura Elisabeth Gressler,Vincent Devlin,Raquel Peat,Danica Marinac-Dabic,Elizabeth Paxton,Art Sedrakyan

International journal of surgery (London, England)（2023）

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摘要

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.

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