Deparment of Orthopaedic Surgery, Duke University School of Medicine, Durham, NC, USA.
Department of Mechanical Engineering and Materials Science, Duke University, Durham, NC, USA.
Foot Ankle Int. 2022 Jun;43(6):750-761. doi: 10.1177/10711007221077113. Epub 2022 Feb 24.
Treating critically sized defects (CSDs) of bone remains a significant challenge in foot and ankle surgery. Custom 3D-printed implants are being offered to a small but growing subset of patients as a salvage procedure in lieu of traditional alternates such as structural allografts after the patient has failed prior procedures. The long-term outcomes of 3D-printed implants are still unknown and understudied because of the limited number of cases and short follow-up durations. The purpose of this study was to evaluate the outcomes of patients who received custom 3D-printed implants to treat CSDs of the foot and ankle in an attempt to aid surgeons in selecting appropriate surgical candidates.
This was a retrospective study to assess surgical outcomes of patients who underwent implantation of a custom 3D-printed implant made with medical-grade titanium alloy powder (Ti-6Al-4V) to treat CSDs of the foot and ankle between June 1, 2014, and September 30, 2019. All patients had failed previous nonoperative or operative management before proceeding with treatment with a custom 3D-printed implant. Univariate and multivariate odds ratios (ORs) of a secondary surgery and implant removal were calculated for perioperative variables.
There were 39 cases of patients who received a custom 3D-printed implant with at least 1 year of follow-up. The mean follow-up time was 27.0 (12-74) months. Thirteen of 39 cases (33.3%) required a secondary surgery and 10 of 39 (25.6%) required removal of the implant because of septic nonunion (6/10) or aseptic nonunion (4/10). The mean time to secondary surgery was 10 months (1-22). Multivariate logistic regression revealed that patients with neuropathy were more likely to require a secondary surgery with an OR of 5.76 ( = .03).
This study demonstrated that 74% of patients who received a custom 3D-printed implant for CSDs did not require as subsequent surgery (minimum of 1-year follow-up). Neuropathy was significantly associated with the need for a secondary surgery. This is the largest series to date demonstrating the efficacy of 3D-printed custom titanium implants. As the number of cases using patient-specific 3D-printed titanium implant increases, larger cohorts of patients should be studied to identify other high-risk groups and possible interventions to improve surgical outcomes.
Level IV, case series.
治疗临界尺寸骨缺损（CSD）仍然是足踝外科的一个重大挑战。作为传统替代物（如结构性同种异体移植物）的替代方案，定制的 3D 打印植入物正逐渐应用于一小部分患者，这些患者在先前的治疗方案失败后，需要进行挽救性治疗。由于病例数量有限，随访时间较短，3D 打印植入物的长期结果仍不清楚，研究也较少。本研究旨在评估接受定制 3D 打印植入物治疗足踝 CSD 的患者的治疗结果，旨在帮助外科医生选择合适的手术候选者。
这是一项回顾性研究，评估了 2014 年 6 月 1 日至 2019 年 9 月 30 日期间接受使用医用级钛合金粉末（Ti-6Al-4V）制造的定制 3D 打印植入物治疗足踝 CSD 的患者的手术结果。所有患者在接受定制 3D 打印植入物治疗之前，都已接受过先前的非手术或手术治疗失败。对围手术期变量进行单变量和多变量优势比（OR）计算，以评估二次手术和植入物取出的可能性。
有 39 例患者接受了定制 3D 打印植入物治疗，随访时间至少为 1 年。平均随访时间为 27.0（12-74）个月。39 例中有 13 例（33.3%）需要进行二次手术，10 例（25.6%）需要取出植入物，原因是感染性骨不连（6/10）或无菌性骨不连（4/10）。二次手术的平均时间为 10 个月（1-22 个月）。多变量逻辑回归显示，有神经病变的患者更有可能需要进行二次手术，OR 为 5.76（ =.03）。
本研究表明，接受定制 3D 打印 CSD 植入物治疗的患者中，有 74%（至少随访 1 年）无需进一步手术。神经病变与需要二次手术显著相关。这是迄今为止最大的系列研究，证明了 3D 打印定制钛植入物的疗效。随着使用患者特定的 3D 打印钛植入物的病例数量增加，应研究更大的患者队列，以确定其他高危人群和可能改善手术结果的干预措施。
IV 级，病例系列研究。
