NCT06996145

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

May 21, 2025

Last Update Submit

March 26, 2026

Conditions

Keywords

anterior cruciate ligamentreconstructionsoftwareplanningtunnelisometrynavigation

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

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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

Locations