Obrador Caterina, Losa-Iglesias Marta, Becerro-de-Bengoa-Vallejo Ricardo, Kabbash Christina A
1 Medcare Orthopedics and Spine Hospital, Dubai, United Arab Emirates.
2 Facultad de Ciencias de la Salud, Universidad Rey Juan Carlos, Alarcón, Madrid, Spain.
Foot Ankle Int. 2018 Apr;39(4):415-425. doi: 10.1177/1071100717745854. Epub 2018 Jan 16.
Temporary Kirschner wire fixation (K-wire) is a widely used, low-cost fixation method for the correction of hammertoe deformity. Reported complications associated with K-wires prompted the development of new implants over the past decade. However, there is a lack of literature on comparative studies analyzing functional outcomes using validated questionnaires. The purpose of this study was to analyze functional outcomes in patients who had undergone proximal interphalangeal joint fusion using 2 types of intramedullary implant, the Smart Toe and the TenFuse, and to compare them with the outcomes in patients treated with standard K-wire fixation.
A retrospective review of operative hammertoe correction by a single surgeon was performed in 96 patients followed for more than 12 months. Functional outcome was assessed using the Foot Function Index (FFI), the Short Form 36 (SF-36), and the 10-point visual analog scale (VAS) validated questionnaires. Complications and fusion rates were also evaluated. Several patients in the study underwent corrections in different toes; thus, a total of 186 toes were included in the study. From these, 65 toes (34.9%) were treated with K-wire fixation, 94 (50.5%) with Smart Toe titanium implant, and 27 (14.5%) with TenFuse allograft implant.
No statistically significant differences in functional outcome and incidence of complications were observed among the 3 fixation groups, although the 2 intramedullary implants were associated with greater fusion rates and patient satisfaction. Breakage of the Smart Toe implant was significantly higher than that of the other fixations, with 10.6% of implants breaking within the first year postoperatively. SF-36 and VAS scores decreased 12 months after surgery for the 3 types of fixation, with no statistically significant differences observed.
The use of Smart Toe and TenFuse implants provided operative outcomes comparable to those obtained using a K-wire fixation and slightly better patient satisfaction. Our results suggest that utilization of these implants for hammertoe correction was a reasonable choice that provided good alignment, pain reduction, and improved function at final follow-up. However, they are more expensive than K-wires. For this reason, in-depth cost-benefit studies would be required to justify their use as a standard treatment.
Level III, comparative series.
临时克氏针固定是一种广泛应用的、低成本的用于矫正锤状趾畸形的固定方法。过去十年间，与克氏针相关的并发症报道促使了新型植入物的研发。然而，缺乏使用经过验证的问卷来分析功能结果的比较研究文献。本研究的目的是分析使用两种髓内植入物（Smart Toe和TenFuse）进行近端指间关节融合的患者的功能结果，并将其与接受标准克氏针固定治疗的患者的结果进行比较。
对一位外科医生进行的96例接受手术矫正锤状趾且随访超过12个月的患者进行回顾性研究。使用足部功能指数（FFI）、简短健康调查问卷36项版本（SF-36）和10分视觉模拟量表（VAS）等经过验证的问卷评估功能结果。还评估了并发症和融合率。研究中的几位患者在不同脚趾进行了矫正；因此，本研究共纳入186个脚趾。其中，65个脚趾（34.9%）采用克氏针固定治疗，94个（50.5%）采用Smart Toe钛植入物治疗，27个（14.5%）采用TenFuse同种异体植入物治疗。
在3个固定组之间，功能结果和并发症发生率没有观察到统计学上的显著差异，尽管两种髓内植入物的融合率和患者满意度更高。Smart Toe植入物的断裂率明显高于其他固定方式，术后第一年有10.6%的植入物发生断裂。3种固定方式术后12个月时SF-36和VAS评分均下降，未观察到统计学上的显著差异。
使用Smart Toe和TenFuse植入物所获得的手术结果与使用克氏针固定相当，患者满意度略高。我们的结果表明，使用这些植入物矫正锤状趾是一个合理的选择，在最终随访时能实现良好的对线、减轻疼痛并改善功能。然而，它们比克氏针更昂贵。因此，需要进行深入的成本效益研究来证明将其作为标准治疗方法的合理性。
III级，比较系列研究。
