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

December 19, 2024 updated by: Yi Mao
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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).
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
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.
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
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.
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
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.
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
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
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
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.
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
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.
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
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.
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
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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yi Mao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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