A Prospective Case-control Clinical Study of the Ultrasound Imaging Reporting and Data System for Diagnosis of Anterosuperior Acetabular Labral Tears

The goal of this clinical trial is to develop an ultrasonic imaging reporting and data system for diagnosis of anterosuperior acetabular labral tears (ALT). Participants will receive a comprehensive clinical diagnosis or a hip arthroscopy to determine whether there is a torn labrum of the hip. Comparing the ultrasonographic characteristics of hip labrum in tear group and non-tear group, establishing diagnostic model is conducive to early diagnosis and differential diagnosis of this disease.

Study Overview

• Status: Completed
• Conditions: Acetabular Labrum Tear; Diagnostic Imaging; Ultrasound Exams; Models

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100036
      • The First Medical Center of the PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the First Medical Center and the Fourth Medical Center of the PLA General Hospital included patients with orthopedic hip discomfort and patients admitted to the ultrasound department without hip injury.

Description

Inclusion criteria: a)18 years of age and above; b) Combined with clinical symptoms, signs, and MRI, a senior orthopaedic surgeon or a final arthroscopy will determine whether the labrum of the hip is torn.

Exclusion criteria: a) other diseases affecting the hip joint (tumors, infections and fractures); b) A history of hip surgery; c)BMI≥30 kg/m²; d) Pregnant patients.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
tear; Patients diagnosed hip labrum tear by a hip arthroscopy or by a comprehensive clinical diagnosis through an orthopaedic surgeon with 15 years of experience
non-tear; Patients no diagnosed hip labrum tear by a hip arthroscopy or by a comprehensive clinical diagnosis through an orthopaedic surgeon with 15 years of experience

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
labral echo homogeneity	Labral echo homogeneity is divided into homogeneous and heterogeneous.	After the completion of data collection and a week of data collation, two ultrasound physicians who had undergone one month of specialized reading training spent two weeks interpreting the hip labrum ultrasound images of all participants.
labral shape	Labral shape was divided into regular and irregular (there are potholes at the lip edge of the labrum or labrum are too full and swollen).	After the completion of data collection and a week of data collation, two ultrasound physicians who had undergone one month of specialized reading training spent two weeks interpreting the hip labrum ultrasound images of all participants.
labral hypoechoic cleft	Whether to tear was divided into yes and no.	After the completion of data collection and a week of data collation, two ultrasound physicians who had undergone one month of specialized reading training spent two weeks interpreting the hip labrum ultrasound images of all participants.
labral focal hyperechoic area	According to whether there is a focal hyperechoic area in the acetabular labrum, it is divided into yes and no.	After the completion of data collection and a week of data collation, two ultrasound physicians who had undergone one month of specialized reading training spent two weeks interpreting the hip labrum ultrasound images of all participants.
labral echogenicity	Echo intensity can be divided into Hypoecho, Isoecho and hyperecho.	After the completion of data collection and a week of data collation, two ultrasound physicians who had undergone one month of specialized reading training spent two weeks interpreting the hip labrum ultrasound images of all participants.
Paralabral cysts	Absent or Present	After the completion of data collection and a week of data collation, two ultrasound physicians who had undergone one month of specialized reading training spent two weeks interpreting the hip labrum ultrasound images of all participants.
Cortical Bone of Ilium	According to the continuity of the cortical bone of the ilium, it can be divided into continuous and interrupted.	After the completion of data collection and a week of data collation, two ultrasound physicians who had undergone one month of specialized reading training spent two weeks interpreting the hip labrum ultrasound images of all participants.
Max cross-section area of labrum	The largest area of the anterior superior labrum of the hip.	After the data collection and a week of data collation, two ultrasound physicians undergone one month of specialized reading training spent two weeks interpreting the hip labrum ultrasound of all participants. Take the average value of three times.
Hip Capsule Thickness	The anterior superior articular capsule of the hip was ultrasonically measured in the thickest area.	After the data collection and a week of data collation, two ultrasound physicians undergone one month of specialized reading training spent two weeks interpreting the hip labrum ultrasound of all participants. Take the average value of three times.
Thickness of Articular Cavity	The ultrasound was located at the longitudinal section of the femoral neck and measured the maximum thickness of the joint cavity of the femoral neck recess.	n and a week of data collation, two ultrasound physicians undergone one month of specialized reading training spent two weeks interpreting the hip labrum ultrasound of all participants. Take the average value of three times.

Collaborators and Investigators

• Sponsor: Yi Mao

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): December 16, 2024

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ChinaPLAGH202412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No