Anterior Cruciate Ligament (ACL)PLANISOLCANCT06996145
Study of the Isometry of the Anterior Cruciate Ligament From the Center of the Native MRI Insertion Reported on Dynamic Scanner
A study testing dynamic 4D scanner in people with Anterior Cruciate Ligament (ACL) and Reconstruction, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
In anterior cruciate ligament (ACL) reconstruction, navigation and robotic assistance now provide the possibility of precise positioning of the tunnels. The challenge is therefore to carry out isometric preoperative planning which can be carried out with robotic or navigation assistance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament (ACL), Reconstruction, Software
- What is being tested?
- dynamic 4D scanner
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2024to 30 Jan 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers aged 18 or older
- Signed informed consent
- Affiliation to a social security system
- Negative pregnancy test for women of childbearing age
Who cannot join
- Volunteer having already undergone knee ligament reconstruction or having peri- or intra-articular knee fractures
- Volunteers for whom ligamentoplasty would not have been the therapeutic option chosen in the event of an ACL rupture
- Pregnant woman
- Volunteer under guardianship or curators, under the protection of justice or deprived of public law.
- Minor volunteer
- Contraindication to MRI or scanner
Trial locations and contacts
1 site in 1 country.
About this study
In anterior cruciate ligament (ACL) reconstruction, navigation and robotic assistance now provide the possibility of precise positioning of the tunnels.
The challenge is therefore to carry out isometric preoperative planning which can be carried out with robotic or navigation assistance.
Read more
In the classic reconstruction technique this isometry is assumed by positioning the tunnels on the center of the native ACL footprints. However, studies cast doubt on this hypothesis.
In this work, the investigators will study the isometry of the center of the native footprints on a dynamic 4D scanner in order to obtain the variation in the distance between the centers of the native footprints during a knee flexion cycle.
This study is part of a larger project. the objective is, if the absence of isometry of the center of the native impressions is confirmed, to develop software assistance which will help the surgeon plan preoperatively an isometric reconstruction. The hypothesis is that the techniques based on the center of the native footprints does not allow isometric reconstruction.
- Conditions
- Anterior Cruciate Ligament (ACL), Reconstruction, Software
- Being tested
- dynamic 4D scanner
- Keywords
- anterior cruciate ligament, reconstruction, software, planning, tunnel, isometry, navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic 4D scannerOther
dynamic 4D scanner
What is being measured
The primary outcome is the main question the study is designed to answer.
variation in length of the ACL
Study of the variation in length of the ACL (isometry) during knee flexion in 4D imaging calculated from the center of the natural footprints of the ACL.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start14 Nov 2024
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament (ACL)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996145
- Sponsor's protocol ID
- PI2024_843_0104
- Acronym
- PLANISOLCA
- Status last verified
- Mar 2026
- First submitted
- 21 May 2025
- Last updated
- 27 Mar 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Isometry of the Anterior Cruciate Ligament From the Center of the Native MRI Insertion Reported on Dynamic Scanner
- ClinicalTrials.gov ID
- NCT06996145
- Acronym / sponsor ID
- PLANISOLCA / PI2024_843_0104
- Conditions
- Anterior Cruciate Ligament (ACL), Reconstruction, Software
- Keywords
- anterior cruciate ligament, reconstruction, software, planning, tunnel, isometry, navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 30 May 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.
In anterior cruciate ligament (ACL) reconstruction, navigation and robotic assistance now provide the possibility of precise positioning of the tunnels.
The challenge is therefore to carry out isometric preoperative planning which can be carried out with robotic or navigation assistance.
In the classic reconstruction technique this isometry is assumed by positioning the tunnels on the center of the native ACL footprints. However, studies cast doubt on this hypothesis.
In this work, the investigators will study the isometry of the center of the native footprints on a dynamic 4D scanner in order to obtain the variation in the distance between the centers of the native footprints during a knee flexion cycle.
This study is part of a larger project. the objective is, if the absence of isometry of the center of the native impressions is confirmed, to develop software assistance which will help the surgeon plan preoperatively an isometric reconstruction. The hypothesis is that the techniques based on the center of the native footprints does not allow isometric reconstruction.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteers aged 18 or older
- Signed informed consent
- Affiliation to a social security system
- Negative pregnancy test for women of childbearing age
Key exclusion criteria (6 listed)
- Volunteer having already undergone knee ligament reconstruction or having peri- or intra-articular knee fractures
- Volunteers for whom ligamentoplasty would not have been the therapeutic option chosen in the event of an ACL rupture
- Pregnant woman
- Volunteer under guardianship or curators, under the protection of justice or deprived of public law.
- Minor volunteer
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 |
|---|---|---|
| dynamic 4D scannerdynamic 4D scanner | Other | – |
Primary outcome
variation in length of the ACL
Time frame: 15 days
Study of the variation in length of the ACL (isometry) during knee flexion in 4D imaging calculated from the center of the natural footprints of the ACL.
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 27 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament (ACL)
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Not yet recruiting
Feasibility of a Mindfulness and Physical Activity Promotion Intervention After Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament (ACL) Reconstruction
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
Not yet recruiting
Three-dimensional Biomechanics of the Lower Limbs in Healthy Volunteers: Establishment of a Reference Database Using the MERItest® System
Healthy Adult Participants, Anterior Cruciate Ligament (ACL)
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dynamic 4D scanner in people with Anterior Cruciate Ligament (ACL) and Reconstruction, run by Centre Hospitalier Universitaire, Amiens 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 6 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 27 Mar 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?
variation in length of the ACL (time frame: 15 days). 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 27 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.