Ultrasonographic and MRI Explorations of Infraspinatus Muscle in Postero-superior Rotator Cuff Tear

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ultrasonographic and MRI Explorations of Infraspinatus Muscle in Postero-superior Rotator Cuff Tear

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Other: MRI
* Other: ultrasonographic explorations


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postero-superior Rotator Cuff Tear<br>MRI, ultrasonographic explorations | Other: MRI<br>* MRI on both shoulder<br>Other: ultrasonographic explorations<br>* ultrasound and elastography explorations on both shoulder<br>|
| Other: Healthy Postero-superior Rotator Cuff<br>MRI, ultrasonographic explorations | Other: MRI<br>* MRI on both shoulder<br>Other: ultrasonographic explorations<br>* ultrasound and elastography explorations on both shoulder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI Texture Index (MTI) | MRI texture index (MTI) on the healthy side and pathological side | up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound Texture Index (UTI) | Ultrasound Texture Index (UTI) on the healthy side and pathological side | up to 2 months | 
| velocity of shear wave in m.s-1 | shear wave velocity on the healthy side and pathological side | up to 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotator Cuff Tears, MRI, Ultrasonographic explorations