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

Acetabular Labrum Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04966728
• Other study ID #: M2018096
• Status: Completed
• Start date: May 15, 2018
• Est. completion date: January 21, 2020

Study information

• Verified date: July 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 21, 2020
• Est. primary completion date: December 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acetabular Labrum Tear

Intervention

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

Locations

Country	Name	City	State
China	Department of Ultrasound Diagnosis, Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.