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Clinical and Anatomical Evaluation of Healing of Lesions of the Subscapular Tendon (TENDICICA)

Primary Purpose

Shoulder Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI imaging
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 other trial for Shoulder Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient, male or female, aged ≥ 18 years Patient who has undergone surgical repair for a rupture or rotator cuff injury involving the subscapularis tendon between April and September 2016 and between May 2018 and January 2019 Patient with a lesion of the subscapularis tendon characterized with arthroscopic classification Patient who has previously participated in the classification study of subscapularis tendon injuries based on findings arthroscopy conducted only at the Jean Mermoz Hospital Exclusion Criteria: Patient with a contraindication to MRI

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Shoulder MRI

    Arm Description

    Shoulder MRI will be performed at least 3 years after shoulder surgery

    Outcomes

    Primary Outcome Measures

    Tendon scarring
    Tendon scarring is based on the Sugaya classification from an MRI

    Secondary Outcome Measures

    Fatty infiltration
    The fatty infiltration of the subscapularis muscle is evaluated according to Goutallier's classification

    Full Information

    First Posted
    February 2, 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
    NCT05725603
    Brief Title
    Clinical and Anatomical Evaluation of Healing of Lesions of the Subscapular Tendon
    Acronym
    TENDICICA
    Official Title
    Clinical and Anatomical Evaluation of Healing of Lesions of the Subscapular Tendon
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2024 (Anticipated)
    Study Completion Date
    March 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
    This study is based on the hypothesis that fatty infiltration postoperative is not or only slightly modified after an atomic repair of lesions of the subscapularis tendon according to a new arthroscopic classification.
    Detailed Description
    After repair of isolated lesions of the subscapularis, it is observed, in nearly half of the cases, a increased fatty infiltration of the subscapularis muscle indicating a probable persistence of the tendon rupture while the Healing failure rate is recognized as moderate (about 15%). This study is based on the hypothesis that fatty infiltration postoperative is not or only slightly modified after an atomic repair of lesions of the subscapularis tendon according to a new arthroscopic classification.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Injuries

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Shoulder MRI
    Arm Type
    Experimental
    Arm Description
    Shoulder MRI will be performed at least 3 years after shoulder surgery
    Intervention Type
    Other
    Intervention Name(s)
    MRI imaging
    Intervention Description
    Shoulder MRI will be performed at least 3 years after shoulder surgery
    Primary Outcome Measure Information:
    Title
    Tendon scarring
    Description
    Tendon scarring is based on the Sugaya classification from an MRI
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    Fatty infiltration
    Description
    The fatty infiltration of the subscapularis muscle is evaluated according to Goutallier's classification
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient, male or female, aged ≥ 18 years Patient who has undergone surgical repair for a rupture or rotator cuff injury involving the subscapularis tendon between April and September 2016 and between May 2018 and January 2019 Patient with a lesion of the subscapularis tendon characterized with arthroscopic classification Patient who has previously participated in the classification study of subscapularis tendon injuries based on findings arthroscopy conducted only at the Jean Mermoz Hospital Exclusion Criteria: Patient with a contraindication to MRI
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Laurent NOVE JOSSERAND, MD
    Phone
    + 33 4 37 53 00 24
    Email
    lnovejosserand.md@orthosanty.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Clinical and Anatomical Evaluation of Healing of Lesions of the Subscapular Tendon

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