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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04223440
Acronym
VISUMIR
Enrollment
3
Registered
2020-01-10
Start date
2020-11-24
Completion date
2021-03-19
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tears

Keywords

Rotator Cuff Tears, MRI, Ultrasonographic explorations

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.

Interventions

OTHERMRI

MRI on both shoulder

OTHERultrasonographic explorations

ultrasound and elastography explorations on both shoulder

Sponsors

University Hospital, Tours
Lead SponsorOTHER
Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MRI Texture Index (MTI)up to 2 monthsMRI texture index (MTI) on the healthy side and pathological side

Secondary

MeasureTime frameDescription
Ultrasound Texture Index (UTI)up to 2 monthsUltrasound Texture Index (UTI) on the healthy side and pathological side
velocity of shear wave in m.s-1up to 2 monthsshear wave velocity on the healthy side and pathological side

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026