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Completed

NCT Number: NCT04223440

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

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.

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Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Tours

Tours, 37044, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Other

MRI on both shoulder

ultrasonographic explorations

Other

ultrasound and elastography explorations on both shoulder

Primary outcomes

  1. MRI Texture Index (MTI)

    Time frame: up to 2 months

    MRI texture index (MTI) on the healthy side and pathological side

Secondary outcomes

  1. Ultrasound Texture Index (UTI)

    Time frame: up to 2 months

    Ultrasound Texture Index (UTI) on the healthy side and pathological side

  2. velocity of shear wave in m.s-1

    Time frame: up to 2 months

    shear wave velocity on the healthy side and pathological side

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Acronym: VISUMIR

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 10, 2020
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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