NCT04966728

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
Last Updated

July 19, 2021

Status Verified

July 1, 2021

Enrollment Period

1.6 years

First QC Date

June 27, 2021

Last Update Submit

July 7, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Comparison of conventional ultrasound diagnosis of the hip joint and arthroscopic diagnosis results

    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

    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

    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.

Study Arms (2)

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

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

Interventions

conventional ultrasound diagnosis of the hip joint, contrast-enhanced ultrasound, and high-resolution single hip MRI

non-hip joint diseasessuspected tear of the anterior superior labrum of the hip

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Mental conditions are not allowed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ultrasound Diagnosis, Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

Study Officials

  • Ligang Cui

    Peking University Third Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 19, 2021

Study Start

May 15, 2018

Primary Completion

December 19, 2019

Study Completion

January 21, 2020

Last Updated

July 19, 2021

Record last verified: 2021-07

Locations