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

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.

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.

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.

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.