Study of the Isometry of the Anterior Cruciate Ligament From the Center of the Native MRI Insertion Reported on Dynamic Scanner

NCT ID: NCT06996145

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-14

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anterior Cruciate Ligament (ACL) Reconstruction Software

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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dynamic 4D scanner

dynamic 4D scanner

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers aged 18 or older
* Signed informed consent
* Affiliation to a social security system
* Negative pregnancy test for women of childbearing age

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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François DEROUSSEN, MD

Role: CONTACT

33+3 22 08 75 76

Facility Contacts

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François DEROUSSEN, MD

Role: primary

33+322087576

Other Identifiers

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PI2024_843_0104

Identifier Type: -

Identifier Source: org_study_id

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