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TRACTOLCA: Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT05806034
Collaborator
(none)
297
Enrollment
1
Location
14.8
Anticipated Duration (Months)
20.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: tractography MRI sequence protocol
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
297 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography
Actual Study Start Date :
Dec 8, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Anisotropy score after tractography MRI sequence [one day]

    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

  2. Correlation between anisotropy coefficient and ACL lesion state [one year]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age ≥ 18 years old,

  • Patient referred for non-enhanced knee MRI for traumatism.

  • Affiliation to a social security program,

Exclusion Criteria:

  • Person under guardianship or curators,

  • Any contraindications to MRI

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Picardie Amiens France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT05806034
Other Study ID Numbers:
  • PI2022_843_0098
First Posted:
Apr 10, 2023
Last Update Posted:
Apr 10, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens
ACL Injury
MRI
tractography
Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Apr 10, 2023