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
About this trial
This is an interventional other trial for Shoulder Injuries
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
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
NCT ID
NCT05725603
First Posted
February 2, 2023
Last Updated
June 23, 2023
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
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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