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

NCT06744192 | Completed

• 1 other identifier: ChinaPLAGH202412
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acetabular Labrum Tear; Ultrasound Exams; Diagnostic Imaging; Models

Outcome Measures

Primary Outcomes (10)

• 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.

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• Yi Mao: lead

Study Sites (1)

The First Medical Center of the PLA General Hospital

Beijing, Beijing Municipality, 100036, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

This study was a non-invasive imaging examination and did not involve sample acquisition

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postgraduate Student, and Research Assistant in Ultrasound Department

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 20, 2024
• Study Start: January 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: December 16, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)