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

Rotator Cuff Tears Clinical Trial

— VISUMIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04223440
• Other study ID #: DR190044
• Status: Recruiting
• Phase: N/A
• Start date: November 24, 2020
• Est. completion date: August 2023

Study information

• Verified date: September 2022
• Source: University Hospital, Tours
• Contact: Guillaume BACLE, PhD
• Phone: 0234389444
• Email: g.bacle[@]chu-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Other:
• MRI
MRI on both shoulder
• ultrasonographic explorations
ultrasound and elastography explorations on both shoulder

Locations

Country	Name	City	State
France	Chu Tours	Tours

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Tours	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI Texture Index (MTI)	MRI texture index (MTI) on the healthy side and pathological side	up to 2 months
Secondary	Ultrasound Texture Index (UTI)	Ultrasound Texture Index (UTI) on the healthy side and pathological side	up to 2 months
Secondary	velocity of shear wave in m.s-1	shear wave velocity on the healthy side and pathological side	up to 2 months