Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography

NCT05806034 | Unknown

• 1 other identifier: PI2022_843_0098
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL Injury; MRI; Tractography

Keywords

ACL Injury; MRI; tractography

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 OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, France

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Central Study Contacts

Wesley BOCQUET, MD

CONTACT

03 22 03 85 21; bocquet.wesley@chu-amiens.fr

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: December 8, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: April 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)