NCT05867069

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
Last Updated

May 19, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

April 25, 2023

Last Update Submit

May 17, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (2)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • (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.

You may not qualify if:

  • (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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yan Xu, M.D.

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 19, 2023

Study Start

September 1, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

May 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations