Ultrasonic Diagnosis of Tear of the Anterior Superior Labrum of the Hip

July 7, 2021 updated by: Peking University Third Hospital
The patients were divided into two groups, one group was a suspected hip joint anterior superior labrum tear, and the other group was a non-hip joint disease. The patients received conventional ultrasound diagnosis of the hip joint, contrast-enhanced ultrasound, and high-resolution single hip MRI for surgery Perform diagnostic power test for the gold standard.

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The patients were divided into two groups, one group was patients with suspected anterior superior labrum tear, and the other group was patients with non-hip joint diseases. Routine ultrasound diagnosis of the hip, contrast-enhanced ultrasound, and high-resolution single hip MRI were performed. For patients undergoing hip arthroscopic surgery after diagnostic occlusive treatment, the results of arthroscopic exploration are used as the diagnostic gold standard. A tear detected during the operation was judged to be positive, and a tear not detected was judged to be negative. For patients who have not undergone hip arthroscopic surgery after the closure treatment, if the MRI of the hip is performed, the MRI result is the gold standard. The diagnosis of tearing was judged as positive, and the undiagnosed tearing was judged as negative. This study was used to compare (1) the diagnostic efficacy of hip joint contrast-enhanced ultrasound and high-resolution single hip MRI in patients with suspected anterior superior labrum tear. (2) Comparison of the diagnostic efficiency of contrast-enhanced hip joint ultrasound and conventional ultrasound in patients with suspected anterior superior labrum tear. (3) In the process of judging the hip joint anterior superior labrum tear by conventional ultrasound and contrast-enhanced ultrasound of the hip joint, the consistency of repeated readings and the comparison of the consistency between readers.

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.
180

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
        • Department of Ultrasound Diagnosis, Peking University Third 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

14 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Case group: Outpatient Department of Sports Medicine, Peking University Third Hospital, clinically diagnosed patients with hip joint labrum tear, preoperative ultrasound examination. Control group: Patients who came to our hospital's ultrasound department at the same time for non-hip joint reasons matched by age, gender and case group.

Description

Inclusion Criteria:

Case group inclusion criteria (1) Age is greater than or equal to 18 years old (2) Patients with preoperative ultrasound examination for clinically planned hip joint anterior superior labrum tear (3) The patient can understand and sign the informed consent form .

Control group inclusion criteria

  1. Age is greater than or equal to 18 years old
  2. Patients who come to the ultrasound department of our hospital for treatment of non-hip joints at the same time
  3. The patient can understand and sign the informed consent form

Exclusion Criteria:

Case group exclusion criteria

  1. Mental conditions are not allowed
  2. Adhesives that are allergic to any known . Control group exclusion criteria (1) Mental conditions are not allowed (2) Adhesives that are allergic to any known (3) Past and current diseases of other hip joint diseases

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.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
suspected tear of the anterior superior labrum of the hip
One group consisted of patients with suspected tear of the anterior superior labrum of the hip.
Diagnostic test: conventional ultrasound diagnosis of the hip joint, contrast-enhanced ultrasound, and high-resolution single hip MRI
conventional ultrasound diagnosis of the hip joint, contrast-enhanced ultrasound, and high-resolution single hip MRI
non-hip joint diseases
For non-hip joint reasons, come to the ultrasound department of our hospital to diagnose patients at the same time, and exclude other past and current hip diseases
Diagnostic test: conventional ultrasound diagnosis of the hip joint, contrast-enhanced ultrasound, and high-resolution single hip MRI
conventional ultrasound diagnosis of the hip joint, contrast-enhanced ultrasound, and high-resolution single hip MRI

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
Comparison of conventional ultrasound diagnosis of the hip joint and arthroscopic diagnosis results
Time Frame: Hip arthroscopy was performed 1 week after ultrasound diagnosis of the hip joint.
Comparison of conventional ultrasound diagnosis of the hip joint and arthroscopic diagnosis results
Hip arthroscopy was performed 1 week after ultrasound diagnosis of the hip joint.
Comparison of conventional contrast-enhanced ultrasound diagnosis of the hip joint and arthroscopic diagnosis results
Time Frame: Hip arthroscopy was performed 1 week after conventional contrast-enhanced ultrasound diagnosis of the hip joint.
Comparison of conventional contrast-enhanced ultrasound diagnosis of the hip joint and arthroscopic diagnosis results
Hip arthroscopy was performed 1 week after conventional contrast-enhanced ultrasound diagnosis of the hip joint.
Comparison of high-resolution single MRI diagnosis of the hip joint and arthroscopic diagnosis results
Time Frame: Hip arthroscopy was performed 1 week after high-resolution single MRI diagnosis of the hip joint.
Comparison of high-resolution single MRI diagnosis of the hip joint and arthroscopic diagnosis results
Hip arthroscopy was performed 1 week after high-resolution single MRI diagnosis of the hip joint.

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.
Peking University Third Hospital

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.
May 15, 2018

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.
December 19, 2019

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.
January 21, 2020

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).
June 27, 2021

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.
July 7, 2021

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.
July 19, 2021

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.
July 19, 2021

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.
July 7, 2021

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.
July 1, 2021

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.
  • M2018096

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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