Acetabular Labrum TearNCT04953598
Ultrasonic Measurement of the Area of the Anterior Superior Labrum of the Hip Joint for Diagnosis of Labrum Tear
An observational study of Acetabular Labrum Tear, run by Peking University Third Hospital at 1 site in China.
Trial summary
In this study, ultrasound diagnosis was performed for patients with hip joint anterior superior labrum tear, and the final surgical observation was used as the gold standard to evaluate the diagnostic efficacy of ultrasonic measurement of the hip joint anterior superior labrum area in the diagnosis of labrum tear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acetabular Labrum Tear
- What is being tested?
- Ultrasonography
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 29 Jul 2018to 5 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- 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
- 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
In this study, ultrasound diagnosis was performed for patients with hip joint anterior superior labrum tear, and the final surgical observation was used as the gold standard to evaluate the diagnostic efficacy of ultrasonic measurement of the hip joint anterior superior labrum area in the diagnosis of labrum tear.
Read the detailed description
In this study, ultrasound diagnosis was performed for patients with a torn anterior superior labrum of the hip joint, and the final surgical observation was the gold standard. The control group selected patients with non-hip joint reasons to come to the ultrasound department of our hospital for diagnosis at the same time. Both the case group and the control group were included in the study at a rate of 1.1 times. This study plans to include 149 cases in the case group and 297 cases in the control group. This study was used to evaluate the diagnostic efficacy of ultrasonic measurement of the area of the anterior superior labrum of the hip in the diagnosis of labrum tears.
- Conditions
- Acetabular Labrum Tear
- Being tested
- Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDiagnostic test
Patient undergoes diagnostic ultrasound examination
| Study group | Role | What they receive |
|---|---|---|
| acetabular labrum tears | Patients with clinically diagnosed acetabular labrum tears Receives: Diagnostic Test: Ultrasonography | |
| Patients with non-hip injuries | 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: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound diagnosis result image
Ultrasound diagnosis as hip joint anterior superior labrum tear
Measured: ultrasound diagnosis were preformed with hip arthroscopy at the same 1 day visiting time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start29 Jul 2018
- Primary completion14 Dec 2019
- Study completion5 Feb 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 160 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
- NCT04953598
- Sponsor's protocol ID
- M2018106
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 8 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 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonic Measurement of the Area of the Anterior Superior Labrum of the Hip Joint for Diagnosis of Labrum Tear
- ClinicalTrials.gov ID
- NCT04953598
- Acronym / sponsor ID
- M2018106
- Conditions
- Acetabular Labrum Tear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 29 Jul 2018 (actual)
- Primary completion
- 14 Dec 2019 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 8 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.
In this study, ultrasound diagnosis was performed for patients with hip joint anterior superior labrum tear, and the final surgical observation was used as the gold standard to evaluate the diagnostic efficacy of ultrasonic measurement of the hip joint anterior superior labrum area in the diagnosis of labrum tear.
Detailed description
In this study, ultrasound diagnosis was performed for patients with a torn anterior superior labrum of the hip joint, and the final surgical observation was the gold standard. The control group selected patients with non-hip joint reasons to come to the ultrasound department of our hospital for diagnosis at the same time. Both the case group and the control group were included in the study at a rate of 1.1 times. This study plans to include 149 cases in the case group and 297 cases in the control group. This study was used to evaluate the diagnostic efficacy of ultrasonic measurement of the area of the anterior superior labrum of the hip in the diagnosis of labrum tears.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acetabular labrum tears | – | Diagnostic Test: UltrasonographyPatients with clinically diagnosed acetabular labrum tears |
| Patients with non-hip injuries | – | Diagnostic Test: UltrasonographyFor 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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 (4 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 (4 listed)
- Case group exclusion criteria
- Mental conditions are not allowed
- Adhesives that are allergic to any known Control group exclusion criteria
- 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 |
|---|---|---|
| UltrasonographyPatient undergoes diagnostic ultrasound examination | Diagnostic test | Patients with non-hip injuries, acetabular labrum tears |
Primary outcome
Ultrasound diagnosis result image
Time frame: ultrasound diagnosis were preformed with hip arthroscopy at the same 1 day visiting time point
Ultrasound diagnosis as hip joint anterior superior labrum tear
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 8 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 4 inclusion and 4 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 8 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?
Ultrasound diagnosis result image (time frame: ultrasound diagnosis were preformed with hip arthroscopy at the same 1 day visiting time point). 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 8 Jul 2021.