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3D Reconstruction of the Knee Based on MRI (IMAGENOU3D)

Primary Purpose

ACL Tear

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Scanner
Sponsored by
GCS Ramsay Santé pour l'Enseignement et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for ACL Tear

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient, male or female, aged between ≥ 18 and ≤ 45 years old Patient eligible for ACL reconstruction Patient with an MRI performed at the SANTY orthopedic center or according to the protocol defined by the radiologists of the orthopedic center SANTY Patient with an MRI performed ≥ 3 weeks after ACL tear Affiliated patient or beneficiary of a social security scheme French-speaking patient who signed an informed consent Exclusion Criteria: Patient with a surgical history on the affected knee Patient with a multi-ligament lesion Patient already included in another study Protected patient: adult under guardianship, curatorship or other protection legal, deprived of liberty by judicial or administrative decision Patient hospitalized without consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Scanner Arm

    Arm Description

    A scanner must be performed by Patients

    Outcomes

    Primary Outcome Measures

    Manual 3D knee reconstruction from MRI and scanner
    Mean IoU (Intersection-Over-Union metric)
    Manual 3D knee reconstruction from MRI and scanner
    DICE coefficient

    Secondary Outcome Measures

    Manual and AI 3D knee reconstruction from MRI
    Mean IoU (Intersection-Over-Union metric)
    Manual and AI 3D knee reconstruction from MRI
    DICE coefficient

    Full Information

    First Posted
    June 12, 2023
    Last Updated
    June 23, 2023
    Sponsor
    GCS Ramsay Santé pour l'Enseignement et la Recherche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05912777
    Brief Title
    3D Reconstruction of the Knee Based on MRI
    Acronym
    IMAGENOU3D
    Official Title
    Comparison of a 3D Reconstruction of the Knee Based on MRI With a 3D Reconstruction of the Knee Based on Scanner - Exploratory Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    May 31, 2024 (Anticipated)
    Study Completion Date
    May 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GCS Ramsay Santé pour l'Enseignement et la Recherche

    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
    ACL tear is a pathology of the knee quite common in athletes mainly caused by a twisting movement. The diagnosis of ACL tear can be confirmed by MRI (magnetic resonance imaging). This method makes it possible to visualize the inside of the knee and to diagnose lesions associated with rupture of the ACL (in particular meniscal lesions). Obtaining a 3D model of patients' joints from a imaging is of growing interest to plan the gesture in preoperative but also to evaluate this gesture postoperatively. In orthopedic surgery, the baseline preoperative imaging is MRI. However, 3D models are generally obtained from a scanner-like imaging. In this context, obtaining a 3D model from MRI imaging would make it possible to have a model that fits into the care pathway patients, without subjecting them to irradiation and visualizing anatomical structures not visible on CT. However, the geometric precision and the reproducibility of the 3D reconstructions of joints reconstructed from an MRI remains unknown and must be evaluated to consider their clinical use.
    Detailed Description
    Rupture of the anterior cruciate ligament (ACL) is a pathology of the knee quite common in athletes. The main cause of an ACL tear is, in the majority of cases, an indirect trauma, caused by a twisting movement (example: the foot remains blocked on the ground while the knee rotates in or out). Sometimes the clinical examination of the ACL tear may not be conclusive.This is usually the case when the patient's knee swelling is too large and that clinical tests are then difficult to carry out. The diagnosis of ACL tear can therefore be confirmed by MRI (magnetic resonance imaging). This method makes it possible to visualize the inside of the knee. In addition, the realization of the MRI will also help to diagnose lesions associated with rupture of the ACL and in particular meniscal lesions. This exam has become indispensable and is carried out in the vast majority of cases. Obtaining a 3D model of patients' joints from a imaging is of growing interest. These 3D models allow particular to plan the gesture in preoperative but also to evaluate this gesture postoperatively. In orthopedic surgery, for patients suffering from an ACL tear, the baseline preoperative imaging is MRI. However, 3D models are generally obtained from a scanner-like imaging. This imagery has the advantage of presenting a very good definition of bone tissue but it is not part, for a large number of patients, routine preoperative imaging. It is irradiating and does not allow easy highlighting of other structures such as cartilage or menisci. In this context, obtaining a 3D model from MRI imaging would make it possible to have a model that fits into the care pathway patients, without subjecting them to irradiation and visualizing anatomical structures not visible on CT. However, the geometric precision and the reproducibility of the 3D reconstructions of joints reconstructed from an MRI remains unknown and must be evaluated to consider their clinical use. This is the purpose of this research.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ACL Tear

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Scanner Arm
    Arm Type
    Experimental
    Arm Description
    A scanner must be performed by Patients
    Intervention Type
    Radiation
    Intervention Name(s)
    Scanner
    Intervention Description
    Scanner to be performed by patients
    Primary Outcome Measure Information:
    Title
    Manual 3D knee reconstruction from MRI and scanner
    Description
    Mean IoU (Intersection-Over-Union metric)
    Time Frame
    1 day
    Title
    Manual 3D knee reconstruction from MRI and scanner
    Description
    DICE coefficient
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    Manual and AI 3D knee reconstruction from MRI
    Description
    Mean IoU (Intersection-Over-Union metric)
    Time Frame
    1 day
    Title
    Manual and AI 3D knee reconstruction from MRI
    Description
    DICE coefficient
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient, male or female, aged between ≥ 18 and ≤ 45 years old Patient eligible for ACL reconstruction Patient with an MRI performed at the SANTY orthopedic center or according to the protocol defined by the radiologists of the orthopedic center SANTY Patient with an MRI performed ≥ 3 weeks after ACL tear Affiliated patient or beneficiary of a social security scheme French-speaking patient who signed an informed consent Exclusion Criteria: Patient with a surgical history on the affected knee Patient with a multi-ligament lesion Patient already included in another study Protected patient: adult under guardianship, curatorship or other protection legal, deprived of liberty by judicial or administrative decision Patient hospitalized without consent
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bertrand SONNERY COTTET, MD
    Phone
    + 33 4 37 53 00 22
    Email
    sonnerycottet@aol.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bertrand SONNERY COTTET, MD
    Organizational Affiliation
    GCS RAMSAY SANTE
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    3D Reconstruction of the Knee Based on MRI

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