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NCT05725603 Clinical Trial

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

Shoulder Injuries Clinical Trial

— TENDICICA  

Official title:
Clinical and Anatomical Evaluation of Healing of Lesions of the Subscapular Tendon

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05725603
Other study ID # 2022-A02504-39
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 12, 2023
Est. completion date December 31, 2024

Study information
Verified date January 2024
Source GCS Ramsay Santé pour l'Enseignement et la Recherche
Contact Laurent NOVE JOSSERAND, MD
Phone + 33 4 37 53 00 24
Email lnovejosserand.md@orthosanty.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• MRI imaging
Shoulder MRI will be performed at least 3 years after shoulder surgery

Locations
Country Name City State
France Hôpital Privé Jean Mermoz Lyon

Sponsors (1)
Lead Sponsor Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tendon scarring Tendon scarring is based on the Sugaya classification from an MRI 1 day
Secondary Fatty infiltration The fatty infiltration of the subscapularis muscle is evaluated according to Goutallier's classification 1 day
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