Rodrigues João Carlos, Santos Alexandre Leme Godoy, Prado Marcelo Pires, Alloza José Felipe Marion, Masagão Renato Amaral, Rosemberg Laercio Alberto, Barros Durval do Carmo Santos, Castro Adham do Amaral E, Demange Marco Kawamura, Lenza Mario, Ferretti Mario
Radiologia, Hospital Israelita Albert Einstein, Sao Paulo, Brazil
Radiologia, Universidade de São Paulo Hospital das Clínicas, Sao Paulo, Brazil.
BMJ Open. 2020 Sep 3;10(9):e037239. doi: 10.1136/bmjopen-2020-037239.
Although several imaging options are available for diagnosing syndesmotic injury, a fundamental question that guides treatment remains unanswered. Syndesmotic instability is still challenging to diagnose correctly, and syndesmotic disruption and true syndesmotic instability should be differentiated. Currently, imaging tests quickly diagnose severe syndesmotic instability but have difficulty in diagnosing mild and moderate cases. This study aims to investigate which strategy among an existing CT index test and two new add-on CT index tests with stress manoeuvres more accurately diagnoses syndesmotic instability. The secondary objective is to investigate the participants' disability outcomes by applying the Foot and Ankle Ability Measure questionnaire.
This study of a diagnostic accuracy test will consecutively select individuals older than 18 years with a clinical diagnosis of a suspected acute syndesmotic injury. Three strategies of the CT index test (one in the neutral position and two with stress) will examine the accuracy using MRI as the reference standard. The external rotation and dorsiflexion of the ankle will guide the stress manoeuvres. A comparison of measurements between the injured syndesmosis and the uninjured contralateral side of the same individual will investigate the syndesmotic instability, by evaluating the rotational and translational relationships between the fibula and tibia. Sensitivity, specificity, area under the receiver operating characteristic curve and likelihood analyses will compare the diagnostic accuracies of the strategies.
The Internal Review Board and the Einstein Ethics Committee approved this study (registered number 62100016.5.0000.0071). All participants will receive an oral description of the study's aim, and the choice to participate will be free and voluntary. Participants will be enrolled after they sign the written informed consent form, including the terms of confidentiality. The results will be presented at national and international conferences and published in peer-reviewed journals and social media.
ClinicalTrials.gov Registry (NCT04095598; preresults).
尽管有多种影像学检查方法可用于诊断下胫腓联合损伤，但一个指导治疗的基本问题仍未得到解答。下胫腓联合不稳定的正确诊断仍然具有挑战性，需要区分下胫腓联合中断和真正的下胫腓联合不稳定。目前，影像学检查能够快速诊断严重的下胫腓联合不稳定，但在诊断轻度和中度病例时存在困难。本研究旨在探讨现有CT指标检查以及两种新的附加CT指标应力检查策略中，哪一种能更准确地诊断下胫腓联合不稳定。次要目标是通过应用足踝能力测量问卷来调查参与者的残疾结果。
本诊断准确性测试研究将连续选取年龄在18岁以上、临床诊断为疑似急性下胫腓联合损伤的个体。CT指标检查的三种策略（一种中立位和两种应力位）将以MRI作为参考标准来检验准确性。踝关节的外旋和背屈将指导应力检查。通过评估腓骨和胫骨之间的旋转和平移关系，比较同一受试者受伤的下胫腓联合与未受伤的对侧之间的测量结果，以研究下胫腓联合不稳定情况。敏感性、特异性、受试者操作特征曲线下面积和似然比分析将比较这些策略的诊断准确性。
内部审查委员会和爱因斯坦伦理委员会批准了本研究（注册号62100016.5.0000.0071）。所有参与者将收到关于研究目的的口头描述，参与选择将是自由和自愿的。参与者在签署包括保密条款的书面知情同意书后将被纳入研究。研究结果将在国内和国际会议上展示，并发表在同行评审期刊和社交媒体上。
ClinicalTrials.gov注册库（NCT04095598；预结果）
