Feasibility and efficacy of ultrasound in the diagnosis of discoid lateral meniscus and its classification in children: protocol for a prospective, multicentre, diagnostic test study.

INTRODUCTION

Although ultrasound can reportedly diagnose discoid lateral meniscus (DLM) in children, its widespread application is challenging because the diagnostic criteria are based on qualitative descriptions of DLM morphology rather than quantitative parameters. Additionally, no studies have applied ultrasound in classifying DLM. Therefore, this study aims to establish the quantitative ultrasound parameters that reflect DLM morphology, evaluate the feasibility and validity of these parameters for identifying DLM and their classification, and develop the quantitative ultrasound diagnostic criteria for DLM and their classification in children.

METHODS AND ANALYSIS

Patients will be recruited from the outpatient clinics of the orthopaedics department at West China Hospital, Sichuan University, the Fourth Medical Center of the Chinese People's Liberation Army General Hospital, Xinhua Hospital affiliated with Shanghai Jiao Tong University School of Medicine, Yibin Hospital affiliated with West China Hospital Sichuan University, Suining Central Hospital and the Third Hospital of Mianyang from August 2022 to July 2024. Eligible patients are those aged ≤14 years, with knee symptoms such as pain, locking and limited extension, and who planned to undergo arthroscopic surgery. Exclusion criteria are patients with contraindications to ultrasound examination, such as severe skin damage or fracture around the knee. The sample size is estimated to be 576 cases with a power of 0.9 for hypothesis testing, a two-sided α of 0.05, and an expected sensitivity and specificity of 95%. Three days before surgery, ultrasound will be used to observe the morphology of the lateral meniscus and measure its width, angle α formed by the chord of upper and lower arc-shaped articular surface at the free edge, and the movement distance of the peripheral rim. Participants will be categorised according to the arthroscopy results for the DLM and its classification. The diagnostic performance of each parameter will be assessed and compared in terms of the area under the curve, sensitivity, specificity, and positive and negative predictive values.

ETHICS AND DISSEMINATION

This study was approved by the Ethics Committee of West China Hospital, Sichuan University (approval no. 2022-923), and this approval covers all study hospitals. Written informed consent is required from all participants before enrolment in the study. The study's findings will be disseminated through peer-reviewed publications and conference presentations.

TRIAL REGISTRATION NUMBER

Chinese Clinical Trial Registry (ChiCTR2200062000).