用于治疗距骨骨软骨损伤的双相生物可吸收支架（TruFit Plug）：6至8年随访
Biphasic bioresorbable scaffold (TruFit Plug) for the treatment of osteochondral lesions of talus: 6- to 8-year follow-up.
作者信息
Di Cave Elvira, Versari Pierluigi, Sciarretta Fabio, Luzon David, Marcellini Lorenzo
机构信息
Operative Unit of Orthopaedics and Traumatology, Israelite Hospital, Rome, Italy.
Operative Unit of Orthopaedics and Traumatology, Israelite Hospital, Rome, Italy.
出版信息
Foot (Edinb). 2017 Dec;33:48-52. doi: 10.1016/j.foot.2017.05.005. Epub 2017 Jun 3.
BACKGROUND
The ideal treatment of osteochondral lesions of the talus (OLT) is debatable. The TruFit plug has been investigated as a potential treatment method for osteochondral defects. This is a biphasic scaffold designed to stimulate cartilage and subchondral bone formation. The purpose of this retrospective study was to investigate the long-term functional and MRI outcomes of the TruFit Plug for the treatment of OLT.
METHODS
Twelve consecutive patients treated from March 2007 to April 2009 for OLT were evaluated. Clinical examination included the American Orthopaedic Foot and Ankle Society (AOFAS) ankle score and the visual analog scale (VAS) for pain. MRI scans were optained pre-treatment and at last follow-up. The Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score was used to assess cartilage incorporation.
RESULTS
Mean follow-up was 7.5 years (range, 6.5-8.7 years). The average age was of 38.6 years (range, 22-57 years). The sex ratio between males and females was 3:1 (9 males, 3 females). The mean AOFAS score improved from a preoperative score of 47.2±10.7 to 84.4±8 (p<0.05). According to the postoperative AOFAS scores 1 case obtained excellent results, 9 were classified as good, and 2 were fair. VAS score improved from a preoperative value of 6.9±1.4 points to 1.2±1.1 points at last follow-up (p<0.05). The MOCART score for cartilage repair tissue on postoperative MRI averaged 61.1 points (range, 25-85 points).
CONCLUSIONS
The long-term results suggest that the technique of Trufit Plug for OLT is safe and demonstrates good post-operative scores including improvement of pain and function, with discordant MRI results. However, randomized controlled clinical trials comparing TruFit Plug with an established treatment method are needed to improve synthetic biphasic implants as therapy for osteochondral lesions.
LEVEL OF EVIDENCE
Retrospective case series, Level IV.
背景
距骨骨软骨损伤（OLT）的理想治疗方法存在争议。TruFit 塞已被研究作为骨软骨缺损的一种潜在治疗方法。这是一种双相支架，旨在刺激软骨和软骨下骨的形成。本回顾性研究的目的是调查 TruFit 塞治疗 OLT 的长期功能和 MRI 结果。
方法
对 2007 年 3 月至 2009 年 4 月连续治疗的 12 例 OLT 患者进行评估。临床检查包括美国矫形足踝协会（AOFAS）踝关节评分和疼痛视觉模拟量表（VAS）。在治疗前和最后一次随访时进行 MRI 扫描。采用磁共振软骨修复组织观察（MOCART）评分评估软骨整合情况。
结果
平均随访 7.5 年（范围 6.5 - 8.7 年）。平均年龄为 38.6 岁（范围 22 - 57 岁）。男女比例为 3:1（9 例男性，3 例女性）。AOFAS 平均评分从术前的 47.2±10.7 提高到 84.4±8（p<0.05）。根据术后 AOFAS 评分，1 例结果为优，9 例为良，2 例为中。VAS 评分从术前的 6.9±1.4 分在最后一次随访时提高到 1.2±1.1 分（p<0.05）。术后 MRI 上软骨修复组织的 MOCART 评分平均为 61.1 分（范围 25 - 85 分）。
结论
长期结果表明，TruFit 塞治疗 OLT 的技术是安全的，术后评分良好，包括疼痛和功能改善，但 MRI 结果不一致。然而，需要进行随机对照临床试验，将 TruFit 塞与既定治疗方法进行比较，以改进合成双相植入物作为骨软骨损伤的治疗方法。
证据水平
回顾性病例系列，IV 级。
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