Healthy VolunteerFLEXIGENNCT07016906
MRI Assessment of Knee Kinematics From Extension to Flexion - Exploratory Study
A study testing MRI in people with Healthy Volunteer, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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'. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hawkcell
Marcy-l'Étoile, 69280
Bertrand SONNERY-COTTET, MD, +33437530022, sonnerycottet@aol.com
Bertrand SONNERY-COTTET, MD
About this 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.
Read more
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.
- Conditions
- Healthy Volunteer
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Knee MRI at different degrees of flexion
| Study group | Role | What they receive |
|---|---|---|
| MRI arm | Experimental | Knee MRI at different degrees of flexion Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start8 Jul 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016906
- Sponsor's protocol ID
- 2025-A00579-40
- Acronym
- FLEXIGEN
- Status last verified
- Aug 2026
- First submitted
- 3 Jun 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Assessment of Knee Kinematics From Extension to Flexion - Exploratory Study
- ClinicalTrials.gov ID
- NCT07016906
- Acronym / sponsor ID
- FLEXIGEN / 2025-A00579-40
- Conditions
- Healthy Volunteer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI arm | Experimental | Other: MRIKnee MRI at different degrees of flexion |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Contraindication to MRI
- Joint osteoarthritis
- BMI > 30
- Previous trauma or surgery to the knee
- Recurrence of sprains
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIKnee MRI at different degrees of flexion | Other | MRI arm |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Healthy Volunteer, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bertrand SONNERY-COTTET, MD (+33437530022, sonnerycottet@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
femorotibial knee kinematics (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.