Ultrasonographic and MRI Explorations of Infraspinatus Muscle in Postero-superior Rotator Cuff Tear (VISUMIR)
Primary Purpose
Rotator Cuff Tears
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
ultrasonographic explorations
Sponsored by

About this trial
This is an interventional diagnostic trial for Rotator Cuff Tears focused on measuring Rotator Cuff Tears, MRI, Ultrasonographic explorations
Eligibility Criteria
Inclusion Criteria:
- ≥ 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
Exclusion Criteria:
- 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
Sites / Locations
- Chu ToursRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Postero-superior Rotator Cuff Tear
Healthy Postero-superior Rotator Cuff
Arm Description
MRI, ultrasonographic explorations
MRI, ultrasonographic explorations
Outcomes
Primary Outcome Measures
MRI Texture Index (MTI)
MRI texture index (MTI) on the healthy side and pathological side
Secondary Outcome Measures
Ultrasound Texture Index (UTI)
Ultrasound Texture Index (UTI) on the healthy side and pathological side
velocity of shear wave in m.s-1
shear wave velocity on the healthy side and pathological side
Full Information
NCT ID
NCT04223440
First Posted
January 6, 2020
Last Updated
September 8, 2022
Sponsor
University Hospital, Tours
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT04223440
Brief Title
Ultrasonographic and MRI Explorations of Infraspinatus Muscle in Postero-superior Rotator Cuff Tear
Acronym
VISUMIR
Official Title
Ultrasonographic and MRI Explorations of Infraspinatus Muscle in Postero-superior Rotator Cuff Tear
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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
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.
Detailed Description
The rotator cuff of the shoulder consists of 4 tendinomuscular units including the infraspinatus. This complex system fulfils a double role: stabilization/coaptation (raising the arm) and arm mobility (especially external rotation). Rupture of rotator cuff tendons is frequent (> 80% among chronic shoulder pain). They go with a decrease in muscle volume (amyotrophy) and irreversible fat infiltration. The treatment is medical and then surgical (if necessary). The degrees of atrophy and muscle infiltration (especially infraspinatus) are the criteria of choice for surgery. Actually, they are assessed in MRI according to the classification of Fuchs; it is operator dependent, qualitative and poorly reproducible with a strong inter-observer variability. Our team highlighted (2016) the possibility of using texture analysis software to objectively measure the proportion of fatty tissue on MRI sections of the cuff rotator muscles. This work also showed the possibility of using mode B ultrasound for morphological imaging and shear wave elastography to estimate the elasticity of the infraspinatus. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
Rotator Cuff Tears, MRI, Ultrasonographic explorations
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Postero-superior Rotator Cuff Tear
Arm Type
Experimental
Arm Description
MRI, ultrasonographic explorations
Arm Title
Healthy Postero-superior Rotator Cuff
Arm Type
Other
Arm Description
MRI, ultrasonographic explorations
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
MRI on both shoulder
Intervention Type
Other
Intervention Name(s)
ultrasonographic explorations
Intervention Description
ultrasound and elastography explorations on both shoulder
Primary Outcome Measure Information:
Title
MRI Texture Index (MTI)
Description
MRI texture index (MTI) on the healthy side and pathological side
Time Frame
up to 2 months
Secondary Outcome Measure Information:
Title
Ultrasound Texture Index (UTI)
Description
Ultrasound Texture Index (UTI) on the healthy side and pathological side
Time Frame
up to 2 months
Title
velocity of shear wave in m.s-1
Description
shear wave velocity on the healthy side and pathological side
Time Frame
up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume BACLE, PhD
Phone
0234389444
Ext
+33
Email
g.bacle@chu-tours.fr
Facility Information:
Facility Name
Chu Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume BACLE, PhD
Phone
0234389444
Ext
+33
Email
g.bacle@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Catherine ROUSSEL
Phone
0247479789
Ext
+33
Email
roussel@med.univ-tours.fr
First Name & Middle Initial & Last Name & Degree
Guillaume BACLE, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ultrasonographic and MRI Explorations of Infraspinatus Muscle in Postero-superior Rotator Cuff Tear
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