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

Abstract

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 multicenter 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 ¼ 44 RUI and N ¼ 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 ¼ .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 ¼ .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.

Does Reusable Instrumentation for Four-Anchor Rotator Cuff Repair Offer Decreased Waste Disposal Costs and Lower Waste-Related Carbon Emissions?

“…27 A multicenter study found that single-use instruments not only improved efficiency by reducing OR time but also reduced setup time when compared with reusable instrumentation in total knee arthroplasties. 28 To deploy the medial anchors in the reusable system, the assistant must insert the desired suture through the anchor and then load the anchor onto the inserter. For the lateral anchors, the assistant will load the anchor onto the threaded capturing rod within the cannulated handle and then the surgeon will load the desired suture limbs into the anchor before malleting it into the bone.…”