Ultrasonographic and MRI Explorations of Infraspinatus Muscle in Postero-superior Rotator Cuff Tear
VISUMIR
1 other identifier
interventional
3
1 country
1
Brief Summary
The project aims to evaluate the contribution of texture analysis on MRI sections, and the technical feasibility, reproducibility, and clinical relevance of quantitative ultrasound and elastography to characterize the composition and volume of infraspinatus muscle in postero-superior rotator cuff tears. The perspectives are to optimize the imaging to allow a quantitative, objective and reproducible analysis of the muscle tissue and its characteristics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2020
CompletedFirst Posted
Study publicly available on registry
January 10, 2020
CompletedStudy Start
First participant enrolled
November 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2021
CompletedFebruary 13, 2026
February 1, 2026
4 months
January 6, 2020
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MRI Texture Index (MTI)
MRI texture index (MTI) on the healthy side and pathological side
up to 2 months
Secondary Outcomes (2)
Ultrasound Texture Index (UTI)
up to 2 months
velocity of shear wave in m.s-1
up to 2 months
Study Arms (2)
Postero-superior Rotator Cuff Tear
EXPERIMENTALMRI, ultrasonographic explorations
Healthy Postero-superior Rotator Cuff
OTHERMRI, ultrasonographic explorations
Interventions
ultrasound and elastography explorations on both shoulder
Eligibility Criteria
You may qualify if:
- ≥ 35 years-old and ≤75 years-old
- tendonous, transfixing, postero-superior, unilateral and symptomatic rotator cuff lesions
- controlateral shoulder without symptom, without rotator cuff injuries, without medical ou surgical history
- written informed consent
- affiliation to a social security system
You may not qualify if:
- pregnant woman
- patient under legal protection
- contraindications to MRI
- traumatic or surgical or medical relevant history on shoulder
- general or local disease affecting the skeletal striated muscle
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu Tours
Tours, 37044, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2020
First Posted
January 10, 2020
Study Start
November 24, 2020
Primary Completion
March 19, 2021
Study Completion
March 19, 2021
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share