NCT05806034

Brief Summary

Knees injuries commonly affect the ACL. French current methodology is based on MRI focused on the knee with morphological sequences (T1, DP fat sat) allowing the study of ACL as follows: No lesion / Partial tear / Complete tear. The treatment (kinesitherapy, surgery, no intervention) is defined taking into account several factors such as age, knee laxity, physical activity and outcome of the radiology analysis (partial or complete tear). However, if the classification is straightforward in case of complete tear, it is not possible to establish a quantitative impact on the ACL in case of partial tear. As a consequence, the investigators will analyze the anisotropy coefficient with diffusion tractography. Any patient who undergo a posttraumatic knee MRI at the CHU Amiens Picardie will have an appointment at the 3T "Signa" MRI that has the knee-centric diffusion tractography sequence.

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 Feb 2023

Typical duration for not_applicable

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

February 8, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2026

Completed
Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

March 28, 2023

Last Update Submit

June 10, 2026

Conditions

Keywords

ACL InjuryMRItractography

Outcome Measures

Primary Outcomes (2)

  • Anisotropy score after tractography MRI sequence

    Anisotropy coefficient value is between 0 (isotropic medium) to 1 (fibrillar medium) . Anisotropy coefficient =0 is for total ACL rupture Anisotropy coefficient between 0 end 0.8 is for partial ACL rupture

    one day

  • Correlation between anisotropy coefficient and ACL lesion state

    Anisotropy coefficient value is between 0 (isotropic medium) to 1 (fibrillar medium) . Anisotropy coefficient =0 is for total ACL rupture ACL lesion state are No lesion, Partial tear or Complete tear

    one year

Interventions

tractography MRI sequence protocol does not require injection of contrast agent.

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years old,
  • Patient referred for non-enhanced knee MRI for traumatism.
  • Affiliation to a social security program,

You may not qualify if:

  • Person under guardianship or curators,
  • Any contraindications to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, France

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 10, 2023

Study Start

February 8, 2023

Primary Completion

January 21, 2026

Study Completion

January 21, 2026

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations