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

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Other: MRI; Other: ultrasonographic explorations

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • CHU Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Actual): March 19, 2021
• Study Completion (Actual): March 19, 2021

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: MRI; Rotator Cuff Tears; Ultrasonographic explorations
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: DR190044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No