The long-term revision risk of RSA-tested and non-RSA-tested TKA implants in The Netherlands
a Dutch arthroplasty register study
Thies J.N. Van Der Lelij (Leiden University Medical Center)
Bart G. Pijls (Leiden University Medical Center, Dutch Arthroplasty Register (Landelijke Registratie Orthopedische Interventies))
Bart L. Kaptein (Leiden University Medical Center)
Liza N. van Steenbergen (Dutch Arthroplasty Register (Landelijke Registratie Orthopedische Interventies))
Rob G.H.H. Nelissen (Leiden University Medical Center)
Perla J. Marang-Van de Mheen (TU Delft - Safety and Security Science, Leiden University Medical Center)
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Abstract
Background and purpose — Radiostereometric analysis (RSA) of total knee arthroplasty (TKA) is used as an early safeguard during the phased evidence-based introduction of new implants. The goal of our study was to compare the long-term revision risk between RSA-tested implants and non-RSA-tested implants in the Netherlands using patient-level data. Methods — All primary TKAs between 2007 and 2016 from the Dutch Arthroplasty Register were included, and procedures with an RSA-tested implant were identified. Both all-cause major revision risk and revision risk because of loosening were calculated at 5 and 10 years postoperatively using Kaplan–Meier analyses. Sensitivity analyses were per-formed with stricter definitions of implant characteristics to classify procedures as RSA-tested, to avoid camouflage of different subdesigns within the same brand implant portfolio. Results — 83,638 RSA-tested and 104,105 non-RSA-tested TKAs were included. Cumulative all-cause major revision percentages for the RSA-tested group at 5 and 10 years were 2.2% (95% confidence interval [CI] 2.1–2.3) and 3.6% (CI 3.4–3.7), respectively, compared with 2.5% (CI 2.4–2.6) and 3.3% (CI 3.2–3.4) for the non-RSA-tested group. RSA-tested TKAs showed higher 10-year revision risks because of loosening than non-RSA-tested procedures (1.8%, CI 1.7– 1.9 vs 1.4%, CI 1.3–1.4, respectively). Comparable results were found after stratification by various patient characteristics and with stricter classification approaches. Conclusion — Regarding all-cause revision risk, RSA-tested TKAs had a slightly lower risk at 5 years. However, at 10 years the RSA-tested TKAs had a higher all-cause revision risk and higher revision risk because of loosening compared with the non-RSA-tested TKAs.
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