Abstract

A novel tendon stapler device (TSD) to improve the strength and consistency of primary tendon repairs was recently approved by the U.S. Food and Drug Administration. The authors hypothesized that this TSD would demonstrate faster and superior biomechanical properties compared with a standard suture coaptation. The authors also hypothesized that the TSD biomechanical properties would be consistent across participants with differing tendon repair experiences. Participants included a novice, intermediate, and expert in tendon repairs. Timed comparisons were performed in flexor zones IV and V and extensor zones VI and VII on human cadaver arms. Suture repairs were performed with a modified Kessler technique with a horizontal mattress. TSD repairs were performed on the matched donor arms. Biomechanical testing included 2-mm gap force, ultimate failure load, and mode of failure. In total, 228 tendon coaptations from 12 donor arms were performed and analyzed. TSD coaptations were 3 times faster and withstood nearly 50% higher forces on 2-mm gap testing and roughly 30% higher forces on ultimate failure testing. These findings did not change when the repair times were analyzed by participant. Suture coaptations failed owing to suture pull-through, suture breakage, or knot failure. TSD coaptation failures only occurred from device pull-through. The TSD produces significantly faster and stronger primary tendon coaptations compared with a standard 4-strand core suture repair in human donor arms. The findings demonstrated minimal variability among participants with differing tendon repair experience. Although further investigation is needed, this device has potential to revolutionize tendon repairs.

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