Single Use Instruments for Implanting a Contemporary Total Knee Arthroplasty System Are Accurate, Efficient, and Safe.

Autor: Bugbee WD; Department of Orthopaedic Surgery, Scripps Clinic, La Jolla, CA., Kolessar DJ; Department of Orthopaedic Surgery, Geisinger Musculoskeletal Institute, Wilkes-Barre, PA., Davidson JS; Bone and Joint Centre, Spire Liverpool Hospital, Liverpool, United Kingdom., Gibbon AJ; Orthopaedic Centre, Clifton Park Hospital, York, United Kingdom., Lesko JP; Clinical Research, DePuy Synthes Joint Reconstruction, Inc., Warsaw, IN., Cosgrove KD; Clinical Research, DePuy Synthes Joint Reconstruction, Inc., Warsaw, IN.
Jazyk: angličtina
Zdroj: The Journal of arthroplasty [J Arthroplasty] 2021 Jan; Vol. 36 (1), pp. 135-139.e2. Date of Electronic Publication: 2020 Jul 21.
DOI: 10.1016/j.arth.2020.07.025
Abstrakt: Background: Single use instruments (SUI) is a potential mechanism to improve efficiency and reduce cost in total knee arthroplasty (TKA). New technology requires patient safety and surgical accuracy. A multi-center study of SUI vs reusable mechanical instrumentation (RUI) for a TKA system compared implant placement accuracy and operating room (OR) efficiency.
Methods: Four surgeons implanted 88 primary TKAs, N = 44 RUI and N = 44 SUI. Accuracy was measured radiographically at 3 months. The primary endpoint was non-inferiority of absolute value of mechanical axis alignment. Radiographic endpoints, OR times, and adverse events were also evaluated.
Results: Seventy-five subjects completed the study (41 SUI/34 RUI). The primary endpoint non-inferiority of SUI vs RUI was met, with no significant difference between SUI and RUI in most radiographic parameters (distal femoral varus-valgus, proximal tibial varus-valgus, tibial slope, or subjects within 3° of target); there was a slight difference in femoral component flexion angle (P = .015). SUI and RUI mean (SD) OR set-up times were 18.8 (10.03) and 26.7 (6.93) (P <.001), and surgical times (first incision to last stitch) were 64.6 (16.95) and 60.5 (19.01) (P = .295), respectively. Differences in OR clean-down and anesthesia were not significant. There were no revisions, and there was no significant difference in the number of reported adverse events.
Conclusion: SUI resulted in similar accuracy of implant placement to RUI with decreased OR set-up time and no increase in adverse events. These results support the safety and efficacy of SUI for performing TKA. Further analysis of potential economic and technical advantages is warranted.
(Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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