NCT07016906

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

75
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress90%
May 2025Jun 2026

Study Start

First participant enrolled

May 28, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

June 3, 2025

Last Update Submit

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

EXPERIMENTAL

Knee MRI at different degrees of flexion

Other: MRI

Interventions

MRIOTHER

Knee MRI at different degrees of flexion

MRI arm

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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

Locations