From the Division of Plastic Surgery, Department of Surgery.
Division of Plastic, Reconstructive, and Oral Surgery, Division of Orthopaedic Surgery, Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania.
Plast Reconstr Surg. 2024 Sep 1;154(3):582-591. doi: 10.1097/PRS.0000000000011102. Epub 2023 Sep 29.
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.
一种新型的肌腱吻合器(TSD)最近获得了美国食品和药物管理局的批准,用于改善初级肌腱修复的强度和一致性。作者假设,与标准缝线吻合相比,这种 TSD 将表现出更快和更好的生物力学性能。作者还假设,TSD 的生物力学性能在具有不同肌腱修复经验的参与者中是一致的。
参与者包括肌腱修复的新手、中级和专家。在人体尸体手臂的屈肌区 IV 和 V 以及伸肌区 VI 和 VII 进行了定时比较。缝线修复采用改良的 Kessler 技术,使用水平褥式缝线。TSD 修复在匹配的供体手臂上进行。生物力学测试包括 2mm 间隙力、最终失效载荷和失效模式。
总共对 12 个供体手臂的 228 个肌腱吻合进行了分析。TSD 吻合的速度快 3 倍,在 2mm 间隙测试中承受的力高近 50%,在最终失效测试中承受的力高约 30%。当按参与者分析修复时间时,这些发现没有改变。缝线吻合失败是由于缝线拉脱、缝线断裂或结失败。TSD 吻合的失败仅发生在器械拉脱的情况下。
与标准的 4 股核心缝线修复相比,TSD 在人体供体手臂中产生了明显更快和更强的初级肌腱吻合。这些发现表明,不同肌腱修复经验的参与者之间的差异很小。尽管需要进一步的研究,但这种设备有可能彻底改变肌腱修复。