TY - JOUR
T1 - Evidence-based objective performance criteria for the evaluation of hip and knee replacement devices and technologies
AU - Nieuwenhuijse, Marc J.
AU - Randsborg, Per Henrik
AU - Hyde, Jensen H.
AU - Xi, Wenna
AU - Franklin, Patricia
AU - Sun, Limin
AU - Zheng, Xinyan
AU - Banerjee, Samprit
AU - Mao, Jialin
AU - Aryal, Suvekshya
AU - Chan, Priscilla
AU - Chen, Amanda
AU - Liebeskind, Alexander
AU - Bonangelino, Pablo
AU - Voorhorst, Paul
AU - Gressler, Laura E.
AU - Devlin, Vincent
AU - Peat, Raquel
AU - Marinac-Dabic, Danica
AU - Paxton, Elizabeth
AU - Sedrakyan, Art
N1 - Publisher Copyright:
© 2023 The Author(s). Published by Wolters Kluwer Health, Inc.
PY - 2023/5/1
Y1 - 2023/5/1
N2 - Background: Objective performance criteria (OPC) is a novel method to provide minimum performance standards and improve the regulated introduction of original or incremental device innovations in order to prevent patients from being exposed to potentially inferior designs whilst allowing timely access to improvements. We developed 2-year safety and effectiveness OPC for total hip and knee replacement (THR and TKR). Methods: Analyses of large databases were conducted using various data sources: a systematic literature review; a direct data analysis from The Functional Outcomes Research for Comparative Effectiveness in Total Joint Replacement and Quality Improvement Registry (FORCE-TJR) and the Kaiser Permanente Implant Registry (KPIR); and claims data analyses from longitudinal discharge data in New York and California states. The literature review included U.S. patients (≥ 18 years) who received THR or TKR for primary end-stage osteoarthritis and prospectively collected data on patient-reported outcome measures (PROMs) from at least 100 subjects and/or 2-year implant survival for at least 250 implants. Random effects models were used for meta-analysis. Results: Data were available from a total of 951 100 patients. After screening of 7979 abstracts, 294 studies underwent full-text review and 31 studies contributed to the evidence synthesis (333 995 implants). Direct data analysis of FORCE-TJR contributed 9223 joint replacement patients to the construction of OPC for effectiveness; KPIR contributed 262 044 patients for the construction of OPC for safety. Claims database analysis contributed 345 838 patients to the construction of safety OPC. OPC for safety were constructed for cumulative incidences of 2-year all-cause and septic revision (THR/TKR 2.0%/1.6% and 0.6%/0.7%), and OPC for effectiveness were constructed based on four disease-specific and three general health-related quality of life PROMs (HOOS/KOOS 87.1/80.6; HSS/KSS function 94.4/90.6; SF-12/SF-36, PCS 46.5/41.9, EQ-5D 0.88/0.84). Conclusion: This study is the first to construct a 2-year OPC for the safety and effectiveness of THR and TKR based on U.S. real-world data. Based on these OPC, potential benchmarks for (single-arm study) evaluation of new device innovations are suggested for a regulated and safe introduction to the (commercial) market.
AB - Background: Objective performance criteria (OPC) is a novel method to provide minimum performance standards and improve the regulated introduction of original or incremental device innovations in order to prevent patients from being exposed to potentially inferior designs whilst allowing timely access to improvements. We developed 2-year safety and effectiveness OPC for total hip and knee replacement (THR and TKR). Methods: Analyses of large databases were conducted using various data sources: a systematic literature review; a direct data analysis from The Functional Outcomes Research for Comparative Effectiveness in Total Joint Replacement and Quality Improvement Registry (FORCE-TJR) and the Kaiser Permanente Implant Registry (KPIR); and claims data analyses from longitudinal discharge data in New York and California states. The literature review included U.S. patients (≥ 18 years) who received THR or TKR for primary end-stage osteoarthritis and prospectively collected data on patient-reported outcome measures (PROMs) from at least 100 subjects and/or 2-year implant survival for at least 250 implants. Random effects models were used for meta-analysis. Results: Data were available from a total of 951 100 patients. After screening of 7979 abstracts, 294 studies underwent full-text review and 31 studies contributed to the evidence synthesis (333 995 implants). Direct data analysis of FORCE-TJR contributed 9223 joint replacement patients to the construction of OPC for effectiveness; KPIR contributed 262 044 patients for the construction of OPC for safety. Claims database analysis contributed 345 838 patients to the construction of safety OPC. OPC for safety were constructed for cumulative incidences of 2-year all-cause and septic revision (THR/TKR 2.0%/1.6% and 0.6%/0.7%), and OPC for effectiveness were constructed based on four disease-specific and three general health-related quality of life PROMs (HOOS/KOOS 87.1/80.6; HSS/KSS function 94.4/90.6; SF-12/SF-36, PCS 46.5/41.9, EQ-5D 0.88/0.84). Conclusion: This study is the first to construct a 2-year OPC for the safety and effectiveness of THR and TKR based on U.S. real-world data. Based on these OPC, potential benchmarks for (single-arm study) evaluation of new device innovations are suggested for a regulated and safe introduction to the (commercial) market.
KW - objective performance criteria
KW - orthopedic surgery
KW - patient-reported outcome measures
KW - real-world evidence
KW - total joint arthroplasty
UR - https://www.scopus.com/pages/publications/85160201328
UR - https://www.scopus.com/inward/citedby.url?scp=85160201328&partnerID=8YFLogxK
U2 - 10.1097/JS9.0000000000000169
DO - 10.1097/JS9.0000000000000169
M3 - Article
C2 - 37026873
AN - SCOPUS:85160201328
SN - 1743-9191
VL - 109
SP - 1125
EP - 1135
JO - International Journal of Surgery
JF - International Journal of Surgery
IS - 5
ER -