踝关节不同姿势下MRI检查对其周围韧带及肌腱损伤的诊断价值：单中心、诊断性试验

摘要

背景：踝关节的伸屈动作包括跖屈与背屈，发挥着支撑承重、传递运动和杠杆作用，踝关节损伤常伴有骨折和周围韧带损伤，严重影响踝关节功能。以往对踝关节损伤的诊断主要依赖于临床体征和X射线检查，而X射线检查只能对较为明显的骨折做出诊断，对周围韧带、肌腱等软组织损伤成像效果较差，因此对踝关节损伤诊断不够精确。MRI具有多序列、多平面成像和良好的软组织分辨率的特点，是目前最佳的无创性软组织损伤检查方法，但对于踝关节周围韧带及肌腱损伤的诊断正确性的研究较为罕见。　　目的：试验旨在观察正常体位、完全跖屈及完全背屈动作下，MRI检查对踝关节周围韧带及肌腱损伤患者的诊断情况。　　方法：研究为单中心、前瞻性、诊断性试验方案，在中国河北医科大学第一医院完成。前瞻性收集对象60例，包括踝关节正常者及踝关节周围韧带及肌腱损伤者各30例，分别对各组踝关节进行自然体位、完全跖屈及完全背屈的MRI扫描，比较个体韧带及肌腱于不同扫描体位的扫描结果的差异。试验的主要结局指标为MRI检测完全跖屈体位下各组踝关节周围韧带及肌腱损伤的敏感度；试验的次要结局指标为MRI扫描完全跖屈体位下各组踝关节周围韧带及肌腱损伤的特异度，阳性预测值、阴性预测值、阳性似然比、阴性似然比及诊断正确率；MRI扫描自然体位及完全背屈体位下各组踝关节周围韧带及肌腱损伤的敏感度、特异度、阳性预测值、阴性预测值、阳性似然比、阴性似然比及诊断正确率；MRI扫描显示的踝关节形态。试验于2017年2月8日在北美临床试验注册中心做注册(NCT03049423)。研究方案取得河北医科大学第一医院伦理委员会的批准(批准号：2015076)，并符合世界医学会制定的《赫尔辛基宣言》的要求。所有参与研究的志愿者均仔细阅读并签署知情同意书。　　讨论：观察MRI检查对临床诊断踝关节周围韧带及肌腱损伤的诊断准确率；明确不同体位MRI检查对踝关节各韧带和肌腱损伤的诊断价值；为制定合理的手术治疗方案提供MRI的量化诊断标准。%BACKGROUND:The ankle joint is capable of flexion and extension, including plantar flexion and dorsiflexion, to act as a support and a lever. An ankle injury, often accompanied by fracture and ligament injury, seriously threatens the ankle joint function. Previous diagnosis of ankle injury mainly relied on clinical signs and X-ray examination. However, X-ray examination is not accurate enough for ankle injury diagnosis because it cannot clearly diagnose damage to the surrounding ligaments, tendons and other soft tissues except for obvious fractures. Mutlisequence and multiplanar MRI is currently the optimal noninvasive method for high-resolution determination of soft tissue deformations, but little has been reported on the diagnostic accuracy of ankle ligament and tendon injury. OBJECTIVE:To observe the diagnostic value of MRI for ligament and tendon injury of the ankle in its normal position, and during complete plantar flexion and dorsiflexion. METHODS:It is a single-center, prospective, diagnostic trial that wil be completed at the First Hospital of Hebei Medical University, China. Sixty cases were recruited, including 30 cases of normal ankle joint and 30 cases of ankle ligament and tendon injury. MRI scans of the ankle joint in normal position, complete plantar flexion and complete dorsiflexion were performed in al the cases, and the multi-position MRI results were compared. The primary outcome measure is the sensitivity of MRI to ligament and tendon injury of the ankle during complete plantar flexion. The secondary outcomes include the specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio of MRI to ligament and tendon injury of the ankle during the complete plantar position as wel as rate of correct diagnosis;specificity and sensitivity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio in normal position or during the complete dorsiflexion as wel as rate of correct diagnosis;the morphology of the ankle on the multi-position MRI. This study design was registered at ClinicalTrial.gov (03049423) on February 8, 2017. This study protocol has been approved by the Medical Ethics Committee of Qinghai University Affiliated Hospital of China (approval No. 2015076) and wil be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Signed informed consent regarding trial procedure and treatment was obtained from each volunteer. DISCUSSION:This study aims to determine the rate of correct diagnosis of ankle ligament and tendon injury using the MRI, to clarify the diagnostic value of MRI for ankle ligament and tendon injury, and to provide a quantitative MRI diagnostic standard for developing a reasonable surgical treatment.