Study of the Isometry of the Anterior Cruciate Ligament From the Center of the Native MRI Insertion Reported on Dynamic Scanner
PLANISOLCA
1 other identifier
interventional
30
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2024
1 active site
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 Start
First participant enrolled
November 14, 2024
CompletedFirst Submitted
Initial submission to the registry
May 21, 2025
CompletedFirst Posted
Study publicly available on registry
May 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2026
CompletedMarch 27, 2026
March 1, 2026
1.2 years
May 21, 2025
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
15 days
Interventions
dynamic 4D scanner
Eligibility Criteria
You may qualify if:
- Healthy volunteers aged 18 or older
- Signed informed consent
- Affiliation to a social security system
- Negative pregnancy test for women of childbearing age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU Amiens
Amiens, 80480, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2025
First Posted
May 30, 2025
Study Start
November 14, 2024
Primary Completion
January 30, 2026
Study Completion
January 30, 2026
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share