Femoro Acetabular ImpingementNCT05867069
Analysis of Radiographic and Kinematic Features in FAI Patients
An observational study of Femoro Acetabular Impingement, run by Peking University Third Hospital at 1 site in China.
Trial summary
The goal of this observational study is to describe the radiographic and kinematic features in patients with femoroacetabular impingement syndrome (FAI). The main questions it aims to answer are: Is structural knee abnormalities associated with knee pain symptoms in FAI patients? Does FAI patients with knee pain… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Femoro Acetabular Impingement
- How many people
- 93 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 28 Feb 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients diagnosed with FAI and admitted into the sports medicine department at Peking university third hospital for hip arthroscopic surgery by a single surgeon.
Who may be able to join
- (1) diagnosed with FAI based on clinical and radiographical findings;
- (2) failed conservative treatment for at least 6 months and indicated for surgical treatment;
- (3) received routine preoperative hip and ipsilateral knee MRI.
Who cannot join
- (1) history of fracture or surgery of hip and knee;
- (2) avascular necrosis;
- (3) Legg-Calve-Perthes disease;
- (4) Ehlers-Danlos syndrome;
- (5) pigmented villonodular synovitis (PVNS);
- (6) osteoid osteoma (OO);
Show all 9Show fewer
- (7) synovial chondromatosis;
- (8) severe hip osteoarthritis (OA) with Tönnis grade > 1;
- (9) developmental dysplasia of hip (DDH)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Knee MRI and Markerless Motion Capture Analysis in Patients With Femoroacetabular Impingement Syndrome
The goal of this observational study is to describe the radiographic and kinematic features in patients with femoroacetabular impingement syndrome (FAI). The main questions it aims to answer are:
- Is structural knee abnormalities associated with knee pain symptoms in FAI patients?
- Does FAI patients with knee pain demonstrate unique kinematic characteristics？ Participants will receive routine preoperative radiographic examinations, which include ipsilateral knee MRI for the purpose of femoral version measurement. Participants will also receive markerless motion capture analysis.
Researchers will compare preoperative radiographic and kinematic features based on knee pain status, which is routinely collected as part of clinical investigation procedures.
Read the detailed description
This observational study aims to study the association between preoperative subjective knee pain and baseline knee radiographic and kinematic characteristics. MRI of the ipsilateral knee is screened for structural abnormalities, including cartilage defects, meniscal tears and ligament injuries. Markerless motion capture data are evaluated for transverse plane kinematic features, with a primary focus on foot progression angles during normal gait.
- Conditions
- Femoro Acetabular Impingement
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ipsilateral knee pain group | Those FAI patients presenting with preoperative ipsilateral knee pain. | |
| No ipsilateral knee pain group | Those FAI patients presenting without preoperative ipsilateral knee pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative radiographic cartilage defect of ipsilateral knee
On the same day of admission, patients receive routine preoperative MRI examination of the hip and ipsilateral knee for femoral version measurement. Radiographs of ipsilateral knee MRI are evaluated for the presence of structural knee abnormality. Radiographic signs suggesting cartilage defect of the patella, femur and the tibial plateau are collected.
Measured: Knee MRI radiographs are evaluated at baseline.
Preoperative radiographic meniscal tear of ipsilateral knee
On the same day of admission, patients receive routine preoperative MRI examination of the hip and ipsilateral knee for femoral version measurement. Radiographs of ipsilateral knee MRI are evaluated for the presence of structural knee abnormality. Radiographic signs suggesting lateral or medial meniscal tears are collected.
Measured: Knee MRI radiographs are evaluated at baseline.
Preoperative radiographic ligament ruptures of ipsilateral knee
On the same day of admission, patients receive routine preoperative MRI examination of the hip and ipsilateral knee for femoral version measurement. Radiographs of ipsilateral knee MRI are evaluated for the presence of structural knee abnormality. Radiographic signs suggesting ACL tears, PCL tears or collateral ligament ruptures are collected.
Measured: Knee MRI radiographs are evaluated at baseline.
Foot progression angle during normal gait
The next day after admission, patients undergo markerless motion capture evaluation after informed consents are obtained. Movements for motion capture include normal gait, stepping in place, single-leg stance, double-leg squat and forward lunge. Each movement is repeated 2 times. The entire data collection process for each patient takes approximately 120 seconds. Foot progression angle during gait are assessed with MATLAB in a retrospective fashion after completion of patient recruitment.
Measured: Motion capture data are assessed at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 Sep 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoro Acetabular 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Xu, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867069
- Sponsor's protocol ID
- S2021436
- Status last verified
- Apr 2023
- First submitted
- 25 Apr 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee MRI and Markerless Motion Capture Analysis in Patients With Femoroacetabular Impingement Syndrome
- ClinicalTrials.gov ID
- NCT05867069
- Acronym / sponsor ID
- S2021436
- Conditions
- Femoro Acetabular Impingement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 19 May 2023 (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 goal of this observational study is to describe the radiographic and kinematic features in patients with femoroacetabular impingement syndrome (FAI). The main questions it aims to answer are:
- Is structural knee abnormalities associated with knee pain symptoms in FAI patients?
- Does FAI patients with knee pain demonstrate unique kinematic characteristics？ Participants will receive routine preoperative radiographic examinations, which include ipsilateral knee MRI for the purpose of femoral version measurement. Participants will also receive markerless motion capture analysis.
Researchers will compare preoperative radiographic and kinematic features based on knee pain status, which is routinely collected as part of clinical investigation procedures.
Detailed description
This observational study aims to study the association between preoperative subjective knee pain and baseline knee radiographic and kinematic characteristics. MRI of the ipsilateral knee is screened for structural abnormalities, including cartilage defects, meniscal tears and ligament injuries. Markerless motion capture data are evaluated for transverse plane kinematic features, with a primary focus on foot progression angles during normal gait.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ipsilateral knee pain group | – | –Those FAI patients presenting with preoperative ipsilateral knee pain. |
| No ipsilateral knee pain group | – | –Those FAI patients presenting without preoperative ipsilateral knee pain. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients diagnosed with FAI and admitted into the sports medicine department at Peking university third hospital for hip arthroscopic surgery by a single surgeon.
Key inclusion criteria (3 listed)
- (1) diagnosed with FAI based on clinical and radiographical findings;
- (2) failed conservative treatment for at least 6 months and indicated for surgical treatment;
- (3) received routine preoperative hip and ipsilateral knee MRI.
Key exclusion criteria (9 listed)
- (1) history of fracture or surgery of hip and knee;
- (2) avascular necrosis;
- (3) Legg-Calve-Perthes disease;
- (4) Ehlers-Danlos syndrome;
- (5) pigmented villonodular synovitis (PVNS);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preoperative radiographic cartilage defect of ipsilateral knee
Time frame: Knee MRI radiographs are evaluated at baseline.
On the same day of admission, patients receive routine preoperative MRI examination of the hip and ipsilateral knee for femoral version measurement. Radiographs of ipsilateral knee MRI are evaluated for the presence of structural knee abnormality. Radiographic signs suggesting cartilage defect of the patella, femur and the tibial plateau are collected.
Preoperative radiographic meniscal tear of ipsilateral knee
Time frame: Knee MRI radiographs are evaluated at baseline.
On the same day of admission, patients receive routine preoperative MRI examination of the hip and ipsilateral knee for femoral version measurement. Radiographs of ipsilateral knee MRI are evaluated for the presence of structural knee abnormality. Radiographic signs suggesting lateral or medial meniscal tears are collected.
Preoperative radiographic ligament ruptures of ipsilateral knee
Time frame: Knee MRI radiographs are evaluated at baseline.
On the same day of admission, patients receive routine preoperative MRI examination of the hip and ipsilateral knee for femoral version measurement. Radiographs of ipsilateral knee MRI are evaluated for the presence of structural knee abnormality. Radiographic signs suggesting ACL tears, PCL tears or collateral ligament ruptures are collected.
Foot progression angle during normal gait
Time frame: Motion capture data are assessed at baseline.
The next day after admission, patients undergo markerless motion capture evaluation after informed consents are obtained. Movements for motion capture include normal gait, stepping in place, single-leg stance, double-leg squat and forward lunge. Each movement is repeated 2 times. The entire data collection process for each patient takes approximately 120 seconds. Foot progression angle during gait are assessed with MATLAB in a retrospective fashion after completion of patient recruitment.
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 May 2023.
- Individual participant dataSharing planned: No
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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.
Yan Xu, M.D. 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 Femoro Acetabular 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 3 inclusion and 9 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 May 2023. 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?
Preoperative radiographic cartilage defect of ipsilateral knee (time frame: Knee MRI radiographs are evaluated at baseline.). 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 19 May 2023.