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

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: Completed
• Conditions: Acetabular Labrum Tear
• Intervention / Treatment: Diagnostic test: conventional ultrasound diagnosis of the hip joint, contrast-enhanced ultrasound, and high-resolution single hip MRI

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: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Department of Ultrasound Diagnosis, Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2018
• Primary Completion (ACTUAL): December 19, 2019
• Study Completion (ACTUAL): January 21, 2020

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (ACTUAL): July 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID 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