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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
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rotator Cuff Tears focused on measuring Rotator Cuff Tears, MRI, Ultrasonographic explorations

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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
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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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