Acetabular Labrum TearNCT04966728
Ultrasonic Diagnosis of Tear of the Anterior Superior Labrum of the Hip
An observational study of Acetabular Labrum Tear, run by Peking University Third Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Acetabular Labrum Tear
- What is being tested?
- conventional ultrasound diagnosis of the hip joint, contrast-enhanced ultrasound, and high-resolution single hip MRI
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2018to 21 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
- 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
Who cannot join
- Case group exclusion criteria
- Mental conditions are not allowed
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Ultrasound Diagnosis, Peking University Third Hospital
Beijing, Beijing Municipality
About this study
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.
Read the 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.
- Conditions
- Acetabular Labrum Tear
- Being tested
- conventional ultrasound diagnosis of the hip joint, contrast-enhanced ultrasound, and high-resolution single hip MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional ultrasound diagnosis of the hip joint, contrast-enhanced ultrasound, and high-resolution single hip MRIDiagnostic test
conventional ultrasound diagnosis of the hip joint, contrast-enhanced ultrasound, and high-resolution single hip MRI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Diagnostic Test: conventional ultrasound diagnosis of the hip joint, contrast-enhanced ultrasound, and high-resolution single hip MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Hip arthroscopy was performed 1 week after high-resolution single MRI diagnosis of the hip joint.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start15 May 2018
- Primary completion19 Dec 2019
- Study completion21 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetabular Labrum TearStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ligang Cui, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966728
- Sponsor's protocol ID
- M2018096
- Status last verified
- Jul 2021
- First submitted
- 27 Jun 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonic Diagnosis of Tear of the Anterior Superior Labrum of the Hip
- ClinicalTrials.gov ID
- NCT04966728
- Acronym / sponsor ID
- M2018096
- Conditions
- Acetabular Labrum Tear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 MRIOne group consisted of patients with suspected tear of the anterior superior labrum of the hip. |
| non-hip joint diseases | – | Diagnostic Test: conventional ultrasound diagnosis of the hip joint, contrast-enhanced ultrasound, and high-resolution single hip MRIFor 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 |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
- 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
Key exclusion criteria (3 listed)
- Case group exclusion criteria
- Mental conditions are not allowed
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional ultrasound diagnosis of the hip joint, contrast-enhanced ultrasound, and high-resolution single hip MRIconventional ultrasound diagnosis of the hip joint, contrast-enhanced ultrasound, and high-resolution single hip MRI | Diagnostic test | non-hip joint diseases, suspected tear of the anterior superior labrum of the hip |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ligang Cui study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acetabular Labrum Tear, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.