高频超声分层诊断踝关节外侧副韧带3种损伤类型的价值：前瞻性,单中心,诊断性试验方案及预试验结果

《中国组织工程研究》 Chinese Journal of Tissue Engineering Research文章编号:2095-4344(2018)23-03681-063681www.CRTER .org·研究原著·黄丹，主治医师。

通讯作者：何秀珍，主任医师。

广州中医药大学附属佛山市中医院，广东省佛山市 528000中图分类号:R318 文献标识码:B稿件接受：2018-05-25Huang Dan, Attending physician, Guangzhou Orthopedics Hospital, Guangzhou 510045, Guangdong Province, ChinaCorresponding author: He Xiu-zhen, Chiefphysician, Foshan Hospital of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine, Foshan 528000, Guangdong Province, China高频超声分层诊断踝关节外侧副韧带3种损伤类型的价值： 前瞻性，单中心，诊断性试验方案及预试验结果黄 丹1，何秀珍2，杨旭欢1，彭思敏1，伍颖娴1 (1广州市正骨医院，广东省广州市 510045；2广州中医药大学附属佛山市中医院，广东省佛山市 528000)DOI:10.3969/j.issn.2095-4344.0289 ORCID: 0000-0001-9012-5402(黄丹)文章快速阅读：文题释义：踝关节内外侧副韧带损伤：外力作用于踝关节，踝关节韧带出现牵拉、部分断裂或完全断裂，以局部肿胀、疼痛、瘀斑、活动受限、压痛明显等为主要表现的疾病。

韧带：属于致密结缔组织，主要可分为2类：弹性结缔组织和胶原纤维彼此交织成的不规则的致密结缔组织，弹性组织是以弹性纤维为主的致密结缔组织。

摘要背景：踝关节扭伤患者最常出现踝关节外侧副韧带损伤，严重影响踝关节的稳定性及功能，对其进行早期诊断显得异常重要。

目前临床上常用的MRI 检测虽然能够较好的显示踝关节软组织情况，但价格昂贵，不能进行损伤韧带的动态观察。

高频超声技术具有便捷、廉价、可进行动态观察的优势，但其对踝关节外侧副韧带损伤的分层诊断价值少有研究报道。

目的：试验旨在探讨高频超声分层诊断踝关节外侧副韧带挫伤、部分断裂、完全断裂3种损伤类型的价值。

方法：纳入广州市正骨医院踝关节扭伤并接受踝关节韧带修复手术治疗的患者70例为试验组，入院后1 d 均进行损伤侧踝关节高频超声和MRI 检测，随后接受踝关节韧带修复手术治疗；术前以健侧踝关节进行MRI 检测，设为对照组。

比较高频超声分层诊断外侧副韧带挫伤、部分断裂、完全断裂的可行性。

研究的主要结局指标为入院后1 d 高频超声检测踝关节外侧副韧带完全断裂的敏感度，研究的次要结局指标为入院后 1 d 高频超声检测踝关节外侧副韧带挫伤及部分断裂的敏感度；入院后1 d 高频超声显示踝关节外侧副韧带挫伤、部分断裂、完全断裂的特异度、阳性预测值、阴性预测值、诊断正确率、ROC 曲线下面积值及截断点值；入院后1 d 高频超声检测踝关节外侧副韧带形态的成像形态。

作者在预试验中已经完成了53例踝关节急性扭伤患者的观察结果，显示出距腓前韧带及跟腓韧带损伤类型的超声诊断结果与手术或MRI 确诊结果相比，差异无显著性意义(P > 0.05)。

试验经广州市正骨医院医学伦理委员会批准(审批单位：广州市正骨医院医院，审批时间：2018年5月，审批号：2018-05)。

研究符合世界医学会制定的《赫尔辛基宣言》的要求。

参加试验及试验中的个人资料均属保密，将依照法律规定得到保护。

试验设计时间为2018年2月，试验于2018年8月开始招募患者及数据收集，2019年8月完成对象招募，2019年12月进行结果指标分析，2020年3月完成试验。

文章结果将以科学会议报告，或在同行评议的期刊上发表传播。

试验已在中国临床试验注册中心注册(注册号：ChiCTR1800016244)，注册方案版本号1.0。

讨论：试验希望证实高频超声技术相比核磁共振检测在诊断踝关节外侧副韧带损伤类型方面具有较高的诊断价值，能准确诊断并区分出踝关节外侧副韧带挫伤、部分断裂、完全断裂3种损伤类型。

关键词：高频超声；踝关节；外侧副韧带损伤；分层；诊断；挫伤、部分断裂、完全断裂；敏感度；特异度；临床试验主题词：组织工程；踝关节；外侧韧带，踝黄丹，何秀珍，杨旭欢，彭思敏，伍颖娴. 高频超声分层诊断踝关节外侧副韧带3种损伤类型的价值：前瞻性，单中心，诊断性试验方案及预试验结果[J]. 中国组织工程研究，2018，22(23):3681-3686. DOI:10.3969/j.issn.2095-4344.0289ISSN 2095-4344 CN 21-1581/R CODEN: ZLKHAH3682Stratification of injuries to the lateral collateral ligament of the ankle using ultrasound: protocol of a prospective, single-center, diagnostic trial and preliminary resultsHuang Dan 1, He Xiu-zhen 2, Yang Xu-huan 1, Peng Si-min 1, Wu Ying-xian 1 (1Guangzhou Orthopedics Hospital, Guangzhou 510045,Guangdong Province, China; 2Foshan Hospital of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine, Foshan 528000, Guangdong Province, China)AbstractBACKGROUND: Patients with ankle sprain most commonly experience injuries to the lateral collateral ligament (LCL) complex, which affects the stability and function of the ankle. Early diagnosis of LCL complex injuries is extremely important. In clinical practice, magnetic resonance imaging (MRI) displays the soft tissues of the ankle well, but it is expensive and cannot be used for real-time evaluation. Ultrasound (US) has the advantages of ease of operation, low cost, and real-time capability. Some studies have reported on the stratification of injuries to the LCL complex using US. However, there is controversy regarding the injury grading.OBJECTIVE: To investigate the grading of LCL complex injuries (sprain, partial tear, and complete tear) using US.METHODS: Seventy patients with suspected ankle sprain who have an acute ankle sprain history and present with surgical indicators will be scheduled to receive ankle ligament repair surgery in the Guangzhou Orthopedics Hospital, China. On the day after admission, these patients will undergo US and MRI of the injured ankle prior to ankle ligament repair surgery (test group). The contralateral ankle will be included in the control group and will also undergo MRI and US examination prior to surgery. MRI or surgical results will be used as the gold standard for diagnosing LCL complex injuries. The feasibility of stratification of LCL complex injuries (sprain, partial tear, and complete tear) using US will be evaluated. Outcome measures and preliminary results: The primary outcome measure of this study is the sensitivity of US in the diagnosis of complete LCL complex tear. The secondary outcome measures are the sensitivity of US in the diagnosis of sprain and partial tear of the LCL complex; the specificity, positive predictive value, negative predictive value, accuracy, area under the ROC curve (AUC), and cut-off value of US in the diagnosis of sprain, partial tear, and complete tear of the LCL; and US imaging for the anatomy of the LCL complex. The results of 53 patients with acute ankle sprain included in the preliminary study suggest that there is no significant difference in the type of injuries to the talofibular ligament and calcaneofibular ligament between ultrasound diagnosis results and surgical or MRI findings (P > 0.05). This study was approved by Medical Ethics Committee of Guangzhou Orthopedics Hospital, China in May, 2018 (approval No. 2018-05). This study protocol will be performed in strict accordance with the Declaration of Helsinki . The personal information and data of the testing subjects participating in the clinical trials will be confidential and will be protected in accordance with applicable laws and regulations. The studyprotocol was designed in February 2018. Patient recruitment will begin in August 2018 and end in August 2019. Data collection will begin in August 2018. Data analysis will be performed in December 2019. The study will end in March 2020. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800016244). Protocol version (1.0).DISCUSSION: The results of this study will reveal whether US has a higher diagnostic value than MRI in the diagnosis of injuries to the LCL complex, and can correctively diagnosis and identify LCL complex injuries (sprain, partial tear, and complete tear). Subject headings: Tissue Engineering; Ankle Joint; Lateral Ligament, Ankle0 引言 Introduction研究背景：踝关节扭伤患者最常出现踝关节外侧副韧带损伤，严重影响踝关节的稳定性及功能[1-4]，对其进行早期诊断显得异常重要[5-9]。