MRI appearance of injured ligaments and tendons of the ankle in different positions:study protocol for a single-center, diagnostic clinical trial / 中国组织工程研究

ABSTRACT

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.