Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography (TRACTOLCA)
Primary Purpose
ACL Injury, MRI, Tractography
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tractography MRI sequence protocol
Sponsored by
About this trial
This is an interventional other trial for ACL Injury focused on measuring ACL Injury, MRI, tractography
Eligibility Criteria
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
Sites / Locations
- CHU Amiens PicardieRecruiting
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05806034
First Posted
March 28, 2023
Last Updated
March 28, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05806034
Brief Title
Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography
Acronym
TRACTOLCA
Official Title
Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury, MRI, Tractography
Keywords
ACL Injury, MRI, tractography
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
297 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
tractography MRI sequence protocol
Intervention Description
tractography MRI sequence protocol does not require injection of contrast agent.
Primary Outcome Measure Information:
Title
Anisotropy score after tractography MRI sequence
Description
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
Time Frame
one day
Title
Correlation between anisotropy coefficient and ACL lesion state
Description
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
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wesley BOCQUET, MD
Phone
03 22 03 85 21
Email
bocquet.wesley@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wesley BOCQUET, MD
Phone
03 22 03 85 21
Email
bocquet.wesley@chu-amiens.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography
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