Sidiropoulos Konstantinos, Panagopoulos Andreas, Assimakopoulos Stelios F, Givissis Panagiotis, Kouzelis Antonios, Vrachnis Ioannis, Lakoumentas John, Saridis Alkis
Emergency Department, Papageorgiou General Hospital of Thessaloniki, Thessaloniki, Greece.
Medical School, University of Patras, Patras, Greece.
JMIR Res Protoc. 2022 Dec 29;11(12):e39319. doi: 10.2196/39319.
The management of infected metaphyseal nonunion of the tibia is devastating, especially when associated with significant bone loss, poor soft tissues, draining sinuses, axial deformity, knee or ankle joint stiffness, limb discrepancy, and multiresisted pathogens. A systematic review, performed recently by the primary investigators but not yet published, yielded the lack of studies in the field and the huge heterogeneity of the presented results. We found several bias and controversies such as no clear definition of the exact part of the tibia where the nonunion was located, the pathogen causing the fracture-related infection, the number of previous interventions and time to presentation, and the exact type of treatment methods including the use of muscle flaps or bone grafting. Time to final union as a functional score is another important but missing data.
The proposed study is designed to evaluate a sufficient number of patients with infected metaphyseal tibial nonunions using various general health, functional, and bone scores.
This prospective clinical trial study, with a minimum follow-up period of 36 months, focuses on the effectiveness of the Ilizarov method after radical nonunion debridement and targeted antibiotic therapy in patients with infected metaphyseal tibial nonunions. The primary outcomes would be the definite healing of nonunion and infection-free results. Secondary outcomes would be limb alignment and discrepancy, alteration in the patient's quality of life, and functional results. A power analysis calculated a minimum of 11 patients to obtain statistical power, but we aim to include at least 25 patients. Limb discrepancy, clinical validation of infection eradication and fracture healing, radiographic validation, and patient-reported outcome measures will be highlighted and correlated. Statistical analysis of the results will offer data missing from the literature so far. Measurements are scheduled at specific times for each patient: preoperatively, 3 and 6 months postoperatively, 1 month after Ilizarov frame removal, and once per semester afterward until the end of the follow-up period (minimum 36 months). Laboratory evaluation will be assessed once per month. Any complication will be reported and treated when it occurs.
The trial has already started. It was funded in June 2020. As of May 2022, 19 participants have been recruited and no major complications have been noticed yet. Data analysis will be performed after data collection ends, and results will be published afterward.
An infected metaphyseal tibial nonunion is a rare condition with limited treatment options and many controversies. There is no consensus in the literature about the best treatment strategy, and this lack of evidence should be fulfilled.
International Standard Randomized Controlled Trial Number (ISRCTN) 30905788; https://www.isrctn.com/ISRCTN30905788.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39319.
胫骨干骺端感染性骨不连的治疗极具挑战性，尤其是当伴有大量骨质缺损、软组织条件差、引流窦道、轴向畸形、膝关节或踝关节僵硬、肢体不等长以及多重耐药病原体感染时。主要研究者近期进行了一项系统评价，但尚未发表，结果发现该领域研究匮乏，且所呈现的结果存在巨大异质性。我们发现了一些偏差和争议，比如对于骨不连位于胫骨的确切部位、导致骨折相关感染的病原体、既往干预次数和就诊时间，以及包括肌瓣或骨移植使用在内的确切治疗方法类型均无明确界定。作为功能评分的最终愈合时间是另一项重要但缺失的数据。
本拟进行的研究旨在使用各种一般健康、功能和骨评分来评估足够数量的胫骨干骺端感染性骨不连患者。
这项前瞻性临床试验研究的最短随访期为36个月，重点关注在对胫骨干骺端感染性骨不连患者进行彻底的骨不连清创和针对性抗生素治疗后，伊里扎洛夫方法的有效性。主要结局将是骨不连的确定性愈合和无感染结果。次要结局将是肢体对线和不等长、患者生活质量的改变以及功能结果。一项效能分析计算得出至少需要11名患者才能获得统计学效能，但我们的目标是纳入至少25名患者。将重点关注并关联肢体不等长、感染根除和骨折愈合的临床验证、影像学验证以及患者报告的结局指标。结果的统计分析将提供迄今文献中缺失的数据。针对每位患者在特定时间安排测量：术前、术后3个月和6个月、拆除伊里扎洛夫外固定架后1个月，以及此后每学期一次，直至随访期结束（最短36个月）。实验室评估将每月进行一次。任何并发症一旦发生将予以报告和治疗。
该试验已经启动。于2020年6月获得资助。截至2022年5月，已招募19名参与者，尚未发现重大并发症。数据收集结束后将进行数据分析，随后公布结果。
胫骨干骺端感染性骨不连是一种罕见病症，治疗选择有限且存在诸多争议。关于最佳治疗策略，文献中尚无共识，这种证据缺失的情况应得到填补。
国际标准随机对照试验编号（ISRCTN）30905788；https://www.isrctn.com/ISRCTN30905788。
国际注册报告识别码（IRRID）：DERR1-10.2196/39319。
