Duke University, Durham, NC, USA.
Orthopedic Institute of Western Kentucky, Paducah, USA.
Foot Ankle Int. 2024 Nov;45(11):1258-1265. doi: 10.1177/10711007241278947. Epub 2024 Oct 27.
Total talus replacement (TTR) implants are designed to replace the diseased talar anatomy, reduce pain, maintain ankle range of motion, and restore ankle function after conservative treatments have failed. Currently TTR implants are produced by 3D printing a patient-specific implant designed from the patient's preoperative anatomy. TTR surgery using patient-specific implants is a relatively new technique that remains understudied in the literature. Therefore, the purpose of this investigation was to determine the early safety and potential benefit of the TTR implant in patients with talar avascular necrosis.
This retrospective, multicenter, cohort study evaluates the safety and potential benefits of TTR using 3D-printed patient-specific implants across 4 US centers. The primary outcome was the occurrence of early adverse events after TTR surgery. Secondary outcomes including, pain, and physical function were assessed using the pain visual analog scale (VAS), and Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF), respectively.
The study team analyzed 15 patients with more than 1 year of follow-up. The mean duration of follow-up was 25.9 months (range: 18.3-41 months). Although 33.3% (5 of 15) of patients experienced adverse events, primarily occurring within the initial 6 months postoperatively, 93% (14 of 15) of patients reported implant survivorship. Of the 5 cases (33.3%) resulting in an adverse event, 3 (60.0%) were determined to be unrelated to the subject device, 2 (40.0%) were determined to be possibly procedure-related, and none (0%) were determined to be device-related.
Although further studies are needed to compare TTR with the standard of care, the results of this study demonstrate the relative early safety of TTR surgery using a 3D-printed implant for the treatment of challenging talar pathologies. A larger and longer clinical study is required to see if the efficacy of this approach will be statistically and clinically meaningful.
全距骨置换（TTR）植入物旨在替代患病的距骨解剖结构，减轻疼痛，维持踝关节活动范围，并在保守治疗失败后恢复踝关节功能。目前，TTR 植入物是通过 3D 打印患者术前解剖结构设计的患者特异性植入物来生产的。使用患者特异性植入物的 TTR 手术是一种相对较新的技术，在文献中研究较少。因此，本研究的目的是确定 TTR 植入物在距骨缺血性坏死患者中的早期安全性和潜在益处。
这项回顾性、多中心、队列研究评估了在 4 个美国中心使用 3D 打印的患者特异性植入物进行 TTR 的安全性和潜在益处。主要结果是 TTR 手术后早期不良事件的发生。次要结果包括疼痛和身体功能，分别使用疼痛视觉模拟量表（VAS）和患者报告的结果测量信息系统（PROMIS）身体功能（PF）进行评估。
研究小组分析了 15 名随访时间超过 1 年的患者。平均随访时间为 25.9 个月（范围：18.3-41 个月）。尽管 33.3%（15 例中的 5 例）的患者发生了不良事件，主要发生在术后最初 6 个月内，但 93%（15 例中的 14 例）的患者报告了植入物的存活率。在导致不良事件的 5 例（33.3%）中，3 例（60.0%）被认为与受试装置无关，2 例（40.0%）被认为可能与手术过程有关，没有（0%）被认为与装置有关。
尽管需要进一步的研究来比较 TTR 与标准护理，但这项研究的结果表明，使用 3D 打印植入物治疗具有挑战性的距骨病变的 TTR 手术相对早期是安全的。需要进行更大和更长时间的临床研究，以确定这种方法的疗效是否在统计学和临床上有意义。
