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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05867069
Other study ID # S2021436
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date February 28, 2022

Study information

Verified date April 2023
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date February 28, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Locations

Country Name City State
China Peking University Third Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Knee MRI radiographs are evaluated at baseline.
Primary 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. Knee MRI radiographs are evaluated at baseline.
Primary 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. Knee MRI radiographs are evaluated at baseline.
Primary 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. Motion capture data are assessed at baseline.
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