Bernasconi Alessio, Iorio Paolino, Ghani Yaser, Argyropoulos Miltiadis, Patel Shelain, Barg Alexej, Smeraglia Francesco, Balato Giovanni, Welck Matthew
Department of Public Health, Trauma and Orthopaedics, University of Naples Federico II, Naples, Italy.
Foot and Ankle Unit, Royal National Orthopaedic Hospital, Stanmore, UK.
Arch Orthop Trauma Surg. 2022 Aug;142(8):1911-1922. doi: 10.1007/s00402-021-03944-7. Epub 2021 May 11.
Intramedullary locking devices (ILDs) have recently been advocated as a minimally invasive approach to manage displaced intraarticular calcaneal fractures (DIACFs), to minimise complications and improve outcomes. We reviewed clinical and biomechanical studies dealing with commercially available devices to identify their characteristics, efficacy and safety.
Following a PRISMA checklist, Medline, Scopus and EMBASE databases were searched to identify studies reporting the use of ILDs for treating DIACFs. Biomechanical studies were first evaluated. Cohort studies were then reviewed for demographics, surgical technique, postoperative protocol, clinical and radiographic scores, complications and reoperations. The modified Coleman Methodology Score (CMS) was used to assess the quality of studies.
Eleven studies were identified which investigated two devices (Calcanail®, C-Nail®). Three biomechanical studies proved they offered adequate primary stability, stiffness, interfragmentary motion and load to failure. Eight clinical studies (321 feet, 308 patients) demonstrated a positive clinical and radiographic outcome at 16-months average follow-up. Metalware irritation (up to 20%) and temporary nerve entrapment symptoms (up to 30%) were the most common complications, while soft tissue issues (wound necrosis, delayed healing, infection) were reported in 3-5% of cases. Conversion to subtalar fusion was necessary in up to 6% of cases. Four (50%) out of 8 studies were authored by implant designers and in 5 (62%) relevant conflicts of interest were disclosed. Mean (± standard deviation) CMS was 59 ± 9.8, indicating moderate quality.
Treating DIAFCs with ILDs leads to satisfactory clinical outcomes at short-term follow-up, enabling restoration of calcaneal height and improved subtalar joint congruency. Metalware irritation and temporary nerve entrapment symptoms are common complications although wound complications are less frequent than after open lateral approaches. The quality of evidence provided so far is moderate and potentially biased by the conflict of interest, raising concerns about the generalisability of results.
Level V - Review of Level III to V studies.
髓内锁定装置（ILDs）最近被提倡作为一种微创方法来处理移位的关节内跟骨骨折（DIACFs），以尽量减少并发症并改善治疗效果。我们回顾了有关市售装置的临床和生物力学研究，以确定其特点、疗效和安全性。
按照PRISMA清单，检索了Medline、Scopus和EMBASE数据库，以确定报告使用ILDs治疗DIACFs的研究。首先评估生物力学研究。然后回顾队列研究的人口统计学、手术技术、术后方案、临床和影像学评分、并发症及再次手术情况。采用改良的科尔曼方法评分（CMS）来评估研究质量。
共确定了11项研究，这些研究调查了两种装置（Calcanail®、C-Nail®）。三项生物力学研究证明它们提供了足够的初始稳定性、刚度、骨折块间运动和破坏载荷。八项临床研究（321足，308例患者）显示，平均随访16个月时临床和影像学结果良好。金属器械刺激（高达20%）和暂时性神经卡压症状（高达30%）是最常见的并发症，而软组织问题（伤口坏死、愈合延迟、感染）在3%-5%的病例中被报告。高达6%的病例需要转为距下关节融合术。8项研究中有4项（50%）由植入物设计者撰写，其中5项（62%）披露了相关利益冲突。平均（±标准差）CMS为59±9.8，表明质量中等。
使用ILDs治疗DIACFs在短期随访中可获得满意的临床结果，能够恢复跟骨高度并改善距下关节的一致性。金属器械刺激和暂时性神经卡压症状是常见并发症，尽管伤口并发症比外侧切开手术少。目前提供的证据质量中等，且可能因利益冲突而存在偏差，这引发了对结果可推广性的担忧。
V级——III至V级研究的综述。
