Femoroacetabular ImpingementNCT04980209
The Feasibility and Application of Intraoperative Ultrasound to Evaluate Femoral Head Shaping
An observational study of Femoroacetabular Impingement, run by Peking University Third Hospital at 1 site in China.
Trial summary
To assess the feasibility of using intraoperative ultrasound to evaluate the femoral head formation; to evaluate the improvement of the forming effect using the intraoperative ultrasound combined with c-arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- ultrasound evaluation
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 1 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: According to the sequential test, the enrolled patients were divided into ultrasound evaluation group and no ultrasound evaluation group. Inclusion Criteria included patients with hip pain; Cam type (alpha Angle > 50°) impingement and glenoid labrum laceration.
Who may be able to join
- Patients with hip pain;
- Cam type (alpha Angle > 50°) impingement and glenoid labrum laceration
Who cannot join
- Previous hip surgery;
- Patients with subosseous cystic degeneration of synovitis
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Univesity Third Hospital
Beijing, Beijing Municipality, 100191
About this study
To assess the feasibility of using intraoperative ultrasound to evaluate the femoral head formation; to evaluate the improvement of the forming effect using the intraoperative ultrasound combined with c-arm.
Read the detailed description
Ultrasound can provide a multi-directional scan of the femoral head and neck junction, and the range of evaluation is larger than that of the intraoperative c-arm. The study was to assess the feasibility of using intraoperative ultrasound to evaluate the femoral head formation; to evaluate the forming of the femoral head and the improvement of the forming effect using the intraoperative ultrasound combined with c-arm.
- Conditions
- Femoroacetabular Impingement
- Being tested
- ultrasound evaluation
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound evaluationDevice
According to the sequential test, the enrolled patients were divided into ultrasound evaluation group and no ultrasound evaluation group.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonic and c-arm combination group | Ultrasound and c-arm were combined to evaluate intraoperatively conditions Receives: Device: ultrasound evaluation | |
| c-arm group | c-arm group was used to evaluate intraoperatively conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS scale
Visual analogue scale（VAS）was used to measure the pain score. The minimum and maximum values were 0 and 10. The higher score, the worse pain.
Measured: 1 year after operation
MHHS scale
Modified Harris Hip Score (MHHS) scale was used to measure the symptoms of joint. The minimum and maximum values were 0 and 91. The higher score, the better.
Measured: 1 year after operation
Hip CT
Routine postoperative hip CT was used to understand the joint morphology.
Measured: 1 day after operation
Hip X-ray
Routine hip X-ray at the Dunn position was conducted.
Measured: 1 day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 May 2018
- Primary completion1 May 2019
- Study completion1 Dec 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
- 78 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
- Cui Ligang, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980209
- Sponsor's protocol ID
- M2019453
- Status last verified
- Jun 2021
- First submitted
- 2 Jul 2021
- Last updated
- 28 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 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Application of Intraoperative Ultrasound to Evaluate Femoral Head Shaping
- ClinicalTrials.gov ID
- NCT04980209
- Acronym / sponsor ID
- M2019453
- Conditions
- Femoroacetabular Impingement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 28 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.
To assess the feasibility of using intraoperative ultrasound to evaluate the femoral head formation; to evaluate the improvement of the forming effect using the intraoperative ultrasound combined with c-arm.
Detailed description
Ultrasound can provide a multi-directional scan of the femoral head and neck junction, and the range of evaluation is larger than that of the intraoperative c-arm. The study was to assess the feasibility of using intraoperative ultrasound to evaluate the femoral head formation; to evaluate the forming of the femoral head and the improvement of the forming effect using the intraoperative ultrasound combined with c-arm.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic and c-arm combination group | – | Device: ultrasound evaluationUltrasound and c-arm were combined to evaluate intraoperatively conditions |
| c-arm group | – | –c-arm group was used to evaluate intraoperatively conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- According to the sequential test, the enrolled patients were divided into ultrasound evaluation group and no ultrasound evaluation group. Inclusion Criteria included patients with hip pain; Cam type (alpha Angle > 50°) impingement and glenoid labrum laceration.
Key inclusion criteria (2 listed)
- Patients with hip pain;
- Cam type (alpha Angle > 50°) impingement and glenoid labrum laceration
Key exclusion criteria (2 listed)
- Previous hip surgery;
- Patients with subosseous cystic degeneration of synovitis
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 evaluationAccording to the sequential test, the enrolled patients were divided into ultrasound evaluation group and no ultrasound evaluation group. | Device | Ultrasonic and c-arm combination group |
Primary outcome
VAS scale
Time frame: 1 year after operation
Visual analogue scale（VAS）was used to measure the pain score. The minimum and maximum values were 0 and 10. The higher score, the worse pain.
MHHS scale
Time frame: 1 year after operation
Modified Harris Hip Score (MHHS) scale was used to measure the symptoms of joint. The minimum and maximum values were 0 and 91. The higher score, the better.
Hip CT
Time frame: 1 day after operation
Routine postoperative hip CT was used to understand the joint morphology.
Hip X-ray
Time frame: 1 day after operation
Routine hip X-ray at the Dunn position was conducted.
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 28 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.
Cui Ligang 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, 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 2 inclusion and 2 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 28 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?
VAS scale (time frame: 1 year after operation). The study lists 4 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 28 Jul 2021.