ACL TearIMAGENOU3DNCT05912777
3D Reconstruction of the Knee Based on MRI
A study testing Scanner in people with ACL Tear, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
ACL tear is a pathology of the knee quite common in athletes mainly caused by a twisting movement. The diagnosis of ACL tear can be confirmed by MRI (magnetic resonance imaging). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- ACL Tear
- What is being tested?
- Scanner
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 13 Sep 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient, male or female, aged between ≥ 18 and ≤ 45 years old
- Patient eligible for ACL reconstruction
- Patient with an MRI performed at the SANTY orthopedic center or according to the protocol defined by the radiologists of the orthopedic center SANTY
- Patient with an MRI performed ≥ 3 weeks after ACL tear
- Affiliated patient or beneficiary of a social security scheme
- French-speaking patient who signed an informed consent
Who cannot join
- Patient with a surgical history on the affected knee
- Patient with a multi-ligament lesion
- Patient already included in another study
- Protected patient: adult under guardianship, curatorship or other protection legal, deprived of liberty by judicial or administrative decision
- Patient hospitalized without consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of a 3D Reconstruction of the Knee Based on MRI With a 3D Reconstruction of the Knee Based on Scanner - Exploratory Study
ACL tear is a pathology of the knee quite common in athletes mainly caused by a twisting movement. The diagnosis of ACL tear can be confirmed by MRI (magnetic resonance imaging). This method makes it possible to visualize the inside of the knee and to diagnose lesions associated with rupture of the ACL (in particular meniscal lesions).
Obtaining a 3D model of patients' joints from a imaging is of growing interest to plan the gesture in preoperative but also to evaluate this gesture postoperatively. In orthopedic surgery, the baseline preoperative imaging is MRI. However, 3D models are generally obtained from a scanner-like imaging.
Read more
In this context, obtaining a 3D model from MRI imaging would make it possible to have a model that fits into the care pathway patients, without subjecting them to irradiation and visualizing anatomical structures not visible on CT.
However, the geometric precision and the reproducibility of the 3D reconstructions of joints reconstructed from an MRI remains unknown and must be evaluated to consider their clinical use.
Read the detailed description
Rupture of the anterior cruciate ligament (ACL) is a pathology of the knee quite common in athletes. The main cause of an ACL tear is, in the majority of cases, an indirect trauma, caused by a twisting movement (example: the foot remains blocked on the ground while the knee rotates in or out).
Sometimes the clinical examination of the ACL tear may not be conclusive.This is usually the case when the patient's knee swelling is too large and that clinical tests are then difficult to carry out. The diagnosis of ACL tear can therefore be confirmed by MRI (magnetic resonance imaging). This method makes it possible to visualize the inside of the knee. In addition, the realization of the MRI will also help to diagnose lesions associated with rupture of the ACL and in particular meniscal lesions. This exam has become indispensable and is carried out in the vast majority of cases.
Obtaining a 3D model of patients' joints from a imaging is of growing interest. These 3D models allow particular to plan the gesture in preoperative but also to evaluate this gesture postoperatively. In orthopedic surgery, for patients suffering from an ACL tear, the baseline preoperative imaging is MRI. However, 3D models are generally obtained from a scanner-like imaging. This imagery has the advantage of presenting a very good definition of bone tissue but it is not part, for a large number of patients, routine preoperative imaging. It is irradiating and does not allow easy highlighting of other structures such as cartilage or menisci.
In this context, obtaining a 3D model from MRI imaging would make it possible to have a model that fits into the care pathway patients, without subjecting them to irradiation and visualizing anatomical structures not visible on CT.
However, the geometric precision and the reproducibility of the 3D reconstructions of joints reconstructed from an MRI remains unknown and must be evaluated to consider their clinical use. This is the purpose of this research.
- Conditions
- ACL Tear
- Being tested
- Scanner
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScannerRadiation
Scanner to be performed by patients
| Study group | Role | What they receive |
|---|---|---|
| Scanner Arm | Experimental | A scanner must be performed by Patients Receives: Radiation: Scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual 3D knee reconstruction from MRI and scanner
Mean IoU (Intersection-Over-Union metric)
Measured: 1 day
Manual 3D knee reconstruction from MRI and scanner
DICE coefficient
Measured: 1 day
Secondary outcomes (2)
Manual and AI 3D knee reconstruction from MRI
Mean IoU (Intersection-Over-Union metric)
Measured: 1 day
Manual and AI 3D knee reconstruction from MRI
DICE coefficient
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start13 Sep 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL TearStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand SONNERY COTTET, MD, Principal investigator, GCS RAMSAY SANTE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912777
- Sponsor's protocol ID
- 2023-A00531-44
- Acronym
- IMAGENOU3D
- Status last verified
- Jan 2024
- First submitted
- 12 Jun 2023
- 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
- Comparison of a 3D Reconstruction of the Knee Based on MRI With a 3D Reconstruction of the Knee Based on Scanner - Exploratory Study
- ClinicalTrials.gov ID
- NCT05912777
- Acronym / sponsor ID
- IMAGENOU3D / 2023-A00531-44
- Conditions
- ACL Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 22 Jun 2023 (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.
ACL tear is a pathology of the knee quite common in athletes mainly caused by a twisting movement. The diagnosis of ACL tear can be confirmed by MRI (magnetic resonance imaging). This method makes it possible to visualize the inside of the knee and to diagnose lesions associated with rupture of the ACL (in particular meniscal lesions).
Obtaining a 3D model of patients' joints from a imaging is of growing interest to plan the gesture in preoperative but also to evaluate this gesture postoperatively. In orthopedic surgery, the baseline preoperative imaging is MRI. However, 3D models are generally obtained from a scanner-like imaging.
In this context, obtaining a 3D model from MRI imaging would make it possible to have a model that fits into the care pathway patients, without subjecting them to irradiation and visualizing anatomical structures not visible on CT.
However, the geometric precision and the reproducibility of the 3D reconstructions of joints reconstructed from an MRI remains unknown and must be evaluated to consider their clinical use.
Detailed description
Rupture of the anterior cruciate ligament (ACL) is a pathology of the knee quite common in athletes. The main cause of an ACL tear is, in the majority of cases, an indirect trauma, caused by a twisting movement (example: the foot remains blocked on the ground while the knee rotates in or out).
Sometimes the clinical examination of the ACL tear may not be conclusive.This is usually the case when the patient's knee swelling is too large and that clinical tests are then difficult to carry out. The diagnosis of ACL tear can therefore be confirmed by MRI (magnetic resonance imaging). This method makes it possible to visualize the inside of the knee. In addition, the realization of the MRI will also help to diagnose lesions associated with rupture of the ACL and in particular meniscal lesions. This exam has become indispensable and is carried out in the vast majority of cases.
Obtaining a 3D model of patients' joints from a imaging is of growing interest. These 3D models allow particular to plan the gesture in preoperative but also to evaluate this gesture postoperatively. In orthopedic surgery, for patients suffering from an ACL tear, the baseline preoperative imaging is MRI. However, 3D models are generally obtained from a scanner-like imaging. This imagery has the advantage of presenting a very good definition of bone tissue but it is not part, for a large number of patients, routine preoperative imaging. It is irradiating and does not allow easy highlighting of other structures such as cartilage or menisci.
In this context, obtaining a 3D model from MRI imaging would make it possible to have a model that fits into the care pathway patients, without subjecting them to irradiation and visualizing anatomical structures not visible on CT.
However, the geometric precision and the reproducibility of the 3D reconstructions of joints reconstructed from an MRI remains unknown and must be evaluated to consider their clinical use. This is the purpose of this research.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scanner Arm | Experimental | Radiation: ScannerA scanner must be performed by Patients |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient, male or female, aged between ≥ 18 and ≤ 45 years old
- Patient eligible for ACL reconstruction
- Patient with an MRI performed at the SANTY orthopedic center or according to the protocol defined by the radiologists of the orthopedic center SANTY
- Patient with an MRI performed ≥ 3 weeks after ACL tear
- Affiliated patient or beneficiary of a social security scheme
Key exclusion criteria (5 listed)
- Patient with a surgical history on the affected knee
- Patient with a multi-ligament lesion
- Patient already included in another study
- Protected patient: adult under guardianship, curatorship or other protection legal, deprived of liberty by judicial or administrative decision
- Patient hospitalized without consent
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 |
|---|---|---|
| ScannerScanner to be performed by patients | Radiation | Scanner Arm |
Primary outcome
Manual 3D knee reconstruction from MRI and scanner
Time frame: 1 day
Mean IoU (Intersection-Over-Union metric)
Manual 3D knee reconstruction from MRI and scanner
Time frame: 1 day
DICE coefficient
2 secondary outcomes
Manual and AI 3D knee reconstruction from MRI
Time frame: 1 day
Manual and AI 3D knee reconstruction from MRI
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for ACL Tear
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Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
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Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
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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. This study is not recruiting at the moment.
Bertrand SONNERY COTTET, MD principal investigator
GCS RAMSAY SANTE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scanner in people with ACL Tear, 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 6 inclusion and 5 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manual 3D knee reconstruction from MRI and scanner (time frame: 1 day). The study lists 2 primary outcomes in all. 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.