Femoroacetabular ImpingementNCT04968301
Cross-sectional Study of Ultrasonic Diagnosis of Iliac Joint Capsule Muscle
An observational study of Femoroacetabular Impingement and Hip Developmental Dysplasia, run by Peking University Third Hospital at 1 site in China.
Trial summary
In order to investigate the relationship between the iliac joint capsular muscle and the development of the hip joint, this study used ultrasound Doppler to measure the anatomical circumference of the iliac joint capsular muscle to explore the relationship Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Femoroacetabular Impingement, Hip Developmental Dysplasia
- What is being tested?
- ultrasound Doppler
- Type of treatment
- Medical device
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 30 Oct 2019
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients who were admitted to the sports medicine outpatient department of Peking University Third Hospital for hip surgery and volunteers recruited as control group，including 40 patients with developmental dysplasia of the hip 40 femoroacetabular impingement patients and 40 healthy volunteers as the control group.
Who may be able to join
- ≥ 20 years;
- Clinically suspected of DDH or Pincer and underwent surgery
- Understand and sign the informed consent
Who cannot join
- Leggcalve´-Perthes disease
- Muscle diseases
- Hip development disorder
- History of progressive osteoarthritis
- History of hip surgery
- History of arthritis of the hip joint
- With pacemaker or metal in the body
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
Official title: A Cross-sectional Study: the Development of the Hip Joint Was Studied by Measuring the Anatomical Circumference of the Capsular Muscle of the Iliac Joint With Ultrasound Doppler
In order to investigate the relationship between the iliac joint capsular muscle and the development of the hip joint, this study used ultrasound Doppler to measure the anatomical circumference of the iliac joint capsular muscle to explore the relationship
Read the detailed description
In order to investigate the relationship between the iliac joint capsular muscle and the development of the hip joint, this study used ultrasound Doppler to measure the anatomical circumference of the iliac joint capsular muscle to explore the relationship.Ultrasound was used to compare the size of the iliac joint cystic muscle in the three groups: patients with developmental dysplasia of the hip (DDH), patients with Pincer type femoral hip impingement, and normal control group. The shear wave velocity and shear modulus of the iliac joint capsular muscle of three groups were compared to compare the degree of fat infiltration in muscle.
- Being tested
- ultrasound Doppler
- Medical subject headings
- Femoracetabular Impingement, Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound DopplerDevice
A cross-sectional study:the development of the hip joint was studied by measuring the anatomical circumference of the capsular muscle of the iliac joint with ultrasound Doppler
| Study group | Role | What they receive |
|---|---|---|
| hip developmental dysplasia group | patients with developmental dysplasia of hip Receives: Device: ultrasound Doppler | |
| femoroacetabular impingement group | patients with femoroacetabular impingement Receives: Device: ultrasound Doppler | |
| control group | healthy volunteers Receives: Device: ultrasound Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parameter of ultraphonic results
The anatomical circumference of the capsular muscle of the iliac joint was measured by ultrasound Doppler，including the dimensional ultrasonic gram and shear wave elasticity diagram
Measured: Ultraphonic was conducted when patients were included in the study from March to October, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 Mar 2019
- Primary completion30 Aug 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular ImpingementStudies 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cui Ligang, Peking University Third Hospital
- Investigators
- Ligang Cui, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968301
- Sponsor's protocol ID
- M2019122
- Status last verified
- Jun 2021
- First submitted
- 2 Jul 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study: the Development of the Hip Joint Was Studied by Measuring the Anatomical Circumference of the Capsular Muscle of the Iliac Joint With Ultrasound Doppler
- ClinicalTrials.gov ID
- NCT04968301
- Acronym / sponsor ID
- M2019122
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 20 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 order to investigate the relationship between the iliac joint capsular muscle and the development of the hip joint, this study used ultrasound Doppler to measure the anatomical circumference of the iliac joint capsular muscle to explore the relationship
Detailed description
In order to investigate the relationship between the iliac joint capsular muscle and the development of the hip joint, this study used ultrasound Doppler to measure the anatomical circumference of the iliac joint capsular muscle to explore the relationship.Ultrasound was used to compare the size of the iliac joint cystic muscle in the three groups: patients with developmental dysplasia of the hip (DDH), patients with Pincer type femoral hip impingement, and normal control group. The shear wave velocity and shear modulus of the iliac joint capsular muscle of three groups were compared to compare the degree of fat infiltration in muscle.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hip developmental dysplasia group | – | Device: ultrasound Dopplerpatients with developmental dysplasia of hip |
| femoroacetabular impingement group | – | Device: ultrasound Dopplerpatients with femoroacetabular impingement |
| control group | – | Device: ultrasound Dopplerhealthy volunteers |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who were admitted to the sports medicine outpatient department of Peking University Third Hospital for hip surgery and volunteers recruited as control group，including 40 patients with developmental dysplasia of the hip 40 femoroacetabular impingement patients and 40 healthy volunteers as the control group.
Key inclusion criteria (3 listed)
- ≥ 20 years;
- Clinically suspected of DDH or Pincer and underwent surgery
- Understand and sign the informed consent
Key exclusion criteria (7 listed)
- Leggcalve´-Perthes disease
- Muscle diseases
- Hip development disorder
- History of progressive osteoarthritis
- History of hip surgery
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 |
|---|---|---|
| ultrasound DopplerA cross-sectional study:the development of the hip joint was studied by measuring the anatomical circumference of the capsular muscle of the iliac joint with ultrasound Doppler | Device | control group, femoroacetabular impingement group, hip developmental dysplasia group |
Primary outcome
Parameter of ultraphonic results
Time frame: Ultraphonic was conducted when patients were included in the study from March to October, 2019
The anatomical circumference of the capsular muscle of the iliac joint was measured by ultrasound Doppler，including the dimensional ultrasonic gram and shear wave elasticity diagram
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 20 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 principal investigator
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 Femoroacetabular Impingement and Hip Developmental Dysplasia, 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 3 inclusion and 7 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 20 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?
Parameter of ultraphonic results (time frame: Ultraphonic was conducted when patients were included in the study from March to October, 2019). 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 20 Jul 2021.