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Completed

NCT Number: NCT06744192

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Medical Center of the PLA General Hospital

Beijing, Beijing Municipality, 100036, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. labral echo homogeneity

    Time frame: 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 echo homogeneity is divided into homogeneous and heterogeneous.

  2. labral shape

    Time frame: 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 was divided into regular and irregular (there are potholes at the lip edge of the labrum or labrum are too full and swollen).

  3. labral hypoechoic cleft

    Time frame: 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.

    Whether to tear was divided into yes and no.

  4. labral focal hyperechoic area

    Time frame: 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.

    According to whether there is a focal hyperechoic area in the acetabular labrum, it is divided into yes and no.

  5. labral echogenicity

    Time frame: 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.

    Echo intensity can be divided into Hypoecho, Isoecho and hyperecho.

  6. Paralabral cysts

    Time frame: 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.

    Absent or Present

  7. Cortical Bone of Ilium

    Time frame: 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.

    According to the continuity of the cortical bone of the ilium, it can be divided into continuous and interrupted.

  8. Max cross-section area of labrum

    Time frame: 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.

    The largest area of the anterior superior labrum of the hip.

  9. Hip Capsule Thickness

    Time frame: 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.

    The anterior superior articular capsule of the hip was ultrasonically measured in the thickest area.

  10. Thickness of Articular Cavity

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

Yi Mao

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 20, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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