- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05867069
Analysis of Radiographic and Kinematic Features in FAI Patients
May 17, 2023 updated by: Peking University Third Hospital
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
93
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100191
- Peking University Third Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- (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.
Exclusion Criteria:
- (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);
- (7) synovial chondromatosis;
- (8) severe hip osteoarthritis (OA) with Tönnis grade > 1;
- (9) developmental dysplasia of hip (DDH)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Ipsilateral knee pain group
Those FAI patients presenting with preoperative ipsilateral knee pain.
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No ipsilateral knee pain group
Those FAI patients presenting without preoperative ipsilateral knee pain.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Preoperative radiographic cartilage defect of ipsilateral knee
Time Frame: Knee MRI radiographs are evaluated at baseline.
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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.
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Knee MRI radiographs are evaluated at baseline.
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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.
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Knee MRI radiographs are evaluated at baseline.
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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.
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Knee MRI radiographs are evaluated at baseline.
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Foot progression angle during normal gait
Time Frame: Motion capture data are assessed at baseline.
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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.
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Motion capture data are assessed at baseline.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yan Xu, M.D., Peking University Third Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
February 28, 2022
Study Completion (Actual)
February 28, 2022
Study Registration Dates
First Submitted
April 25, 2023
First Submitted That Met QC Criteria
May 17, 2023
First Posted (Actual)
May 19, 2023
Study Record Updates
Last Update Posted (Actual)
May 19, 2023
Last Update Submitted That Met QC Criteria
May 17, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S2021436
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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