MRI Assessment of Knee Kinematics From Extension to Flexion - Exploratory Study
FLEXIGEN
1 other identifier
interventional
36
1 country
1
Brief Summary
During flexion of the knee, internal rotation of the tibia associated with translation of the tibial plateaus in relation to the femoral condyles is automatically induced. This mechanism combines a sliding phenomenon and a rolling phenomenon of the condyles on the plate, the latter being known as 'roll-back'. In 2024, imaging analyses of the knee, and in particular MRI, are carried out with the leg in extension. MRI of the knee at different degrees of flexion would enable to assess the sliding and roll-back phenomena, in order to gain a better understanding of knee kinematics. However, MRI of the knee at different degrees of flexion is limited by the size of the MRI machines and especially by the knee antennae, which are narrow and do not allow flexion beyond 30°. In this context, the only solution for carrying out an MRI study on knees in flexion would be to carry out this examination with an antenna that allows the knee to be positioned at different angles of flexion. This particular type of antenna only exists in veterinary schools, where they are used in particular for horses. Consequently, this study is based on the assumption that the kinematics of the knee can be assessed using MRI with an antenna for veterinary use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2025
1 active site
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
May 28, 2025
CompletedFirst Submitted
Initial submission to the registry
June 3, 2025
CompletedFirst Posted
Study publicly available on registry
June 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
June 12, 2025
June 1, 2025
1.1 years
June 3, 2025
June 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
femorotibial knee kinematics
The kinematics of the knee will be described on the basis the femorotibial contact surfaces at the level of the medial tibial plateau and the lateral tibial plateau at each degree of flexion, during an MRI acquisition. Contact surfaces will be measured in mm2.
Day 1
Study Arms (1)
MRI arm
EXPERIMENTALKnee MRI at different degrees of flexion
Interventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers (no damage to either knee)
- Male or female, aged between 18 and 40
- Healthy volunteer affiliated to or benefiting from a social security scheme
- A healthy French-speaking volunteer who has signed an informed consent form.
You may not qualify if:
- Contraindication to MRI
- Joint osteoarthritis
- BMI \> 30
- Previous trauma or surgery to the knee
- Recurrence of sprains
- Knee trauma other than sprain
- Protected person: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
- Pregnant or breast-feeding woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hawkcell
Marcy-l'Étoile, 69280, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2025
First Posted
June 12, 2025
Study Start
May 28, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
June 12, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share