Stratification of injuries to the lateral collateral ligament of the ankle using ultrasound: protocol of a prospective, single-center, diagnostic trial and preliminary results

doi:10.3969/j.issn.2095-4344.0289

Abstract

Abstract:

BACKGROUND: 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 study protocol 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).

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Tissue Engineering, Ankle Joint, Lateral Ligament, Ankle

CLC Number:

R318

Huang Dan, He Xiu-zhen, Yang Xu-huan, Peng Si-min, Wu Ying-xian. Stratification of injuries to the lateral collateral ligament of the ankle using ultrasound: protocol of a prospective, single-center, diagnostic trial and preliminary results[J]. Chinese Journal of Tissue Engineering Research, 2018, 22(23): 3681-3686.

Figures/Tables 1

References

[1] Zhou L, Sun K, Chen Y, et al. Efficacy of Shangbai ointment in alleviating pain in patients with acute ankle joint lateral collateral ligament injury: a randomized controlled trial. Nan Fang Yi Ke Da Xue Xue Bao. 2017;37(3):398-401.

[2] Tang WJ, Jiang CG, Chen LR, et al. Effects of acupuncture- moxibustion intervention on proprioception in athletes with lateral collateral ligament injury of ankle joint. Zhen Ci Yan Jiu. 2013;38(4):314-318.

[3] Zhou YF, Lu XL, Lai HY, et al. Biomechanical comparison of Evans procedure and Chrisman-Snook technique for the treatment of II degree lateral collateral ligament of ankle joint. Zhongguo Gu Shang. 2012;25(8):654-657.

[4] Kulenovi? E. Nonoperative approach to injuries of the lateral collateral ligament of the ankle joint. Med Arh. 1993;47(3-4): 77-78.

[5] Vuurberg G, Hoorntje A, Wink LM, et al. Diagnosis, treatment and prevention of ankle sprains: update of an evidence-based clinical guideline. Br J Sports Med. 2018. doi: 10.1136/bjsports-2017-098106.

[6] Sun Y, Wang H, Tang Y, et al. Diagnosis and treatment of chronic lateral ankle instability with ligamentum bifurcatum injury: an observational study. Medicine (Baltimore). 2018; 97(9):e0028.

[7] Cho JH, Lee DH, Song HK, et al. Value of stress ultrasound for the diagnosis of chronic ankle instability compared to manual anterior drawer test, stress radiography, magnetic resonance imaging, and arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2016;24(4):1022-1028.

[8] Jung HG, Kim NR, Kim TH, et al. Magnetic resonance imaging and stress radiography in chronic lateral ankle instability. Foot Ankle Int. 2017;38(6):621-626.

[9] Jolman S, Robbins J, Lewis L, et al. Comparison of magnetic resonance imaging and stress radiographs in the evaluation of chronic lateral ankle instability. Foot Ankle Int. 2017;38(4): 397-404.

[10] 郑卓肇,胡跃林,李选,等.踝关节创伤性病变的MRI检查[J]中国医学影像技术,2007,23(6):905-908．

[11] Valderrabano V, Leumann A, Pagenstert G, et al. Chronic ankle instability in sports-a review for sports physicians. Sportverletz Sportschaden. 2006;20(4):177-83.

[12] Bonvin F, Montet X, Copercini M, et al. Imaging of fractures of the lateral process of the talus, a frequently missed diagnosis. Eur J Radiol. 2003;47(1):64-70.

[13] Collard XR, Danse EM, Rombouts JJ. The syndrome of external ligament sprain in the horse. Acta Orthop Belg. 2000; 66(3):229-241.

[14] Milz P, Milz S, Steinborn M, et al. 13-MHc high frequency ultrasound of the lateral ligaments of the ankle joint and the anterior tibia-fibular ligament. Comparison and results of MRI in 64 patients. Radiologe. 1999;39(1):34-40.

[15] Chhabra A, Subhawong TK, Carrino JA. MR imaging of deltoid ligament pathologic findings and associated impingement syndromes. Radiographics. 2010;30(3): 751-761.

[16] 王月香.肌骨超声必读[M].北京:科学出版社,2017.

[17] 董相宇,曾效力,何秀珍,等.MRI和高频超声对踝关节外侧副韧带损伤的诊断价值比较[J].现代医用影像学,2015,24(2):140-144.