Background: A novel tendon stapler device (TSD) was recently developed and FDA-approved to improve the strength and consistency of primary tendon repairs. We hypothesized this TSD would demonstrate faster and superior biomechanical properties compared to a standard suture coaptation. We also hypothesized that the TSD biomechanical properties would be consistent across participants with differing tendon repair experience.
Methods: Participants included a novice, intermediate, and expert in tendon repairs. Timed comparisons were performed in flexor zones IV-V and extensor zones VI-VII on human cadaver arms. Suture repairs were performed with a modified Kessler 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.
Results: In total, 228 tendon coaptations from 12 donor arms were performed and analyzed. TSD coaptations were three times faster and withstood nearly 50% higher forces on the 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 individual participants. The suture coaptations failed from suture pull-through, suture breakage, and knot failure. The TSD coaptation failures only occurred from device pull-through.
Conclusion: The TSD produces significantly faster and stronger primary tendon coaptations compared to a standard 4-strand core suture repair in human donor arms. These findings also 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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