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Active, Not Recruiting

NCT Number: NCT07016906

MRI Assessment of Knee Kinematics From Extension to Flexion - Exploratory Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy Volunteer

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hawkcell

Marcy-l'Étoile, 69280, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

MRI

Other

Knee MRI at different degrees of flexion

Primary outcomes

  1. femorotibial knee kinematics

    Time frame: Day 1

    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.

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: FLEXIGEN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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