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

NCT ID: NCT04223440

Last Updated: 2022-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-24

Study Completion Date

2023-08-31

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.

Conditions

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Rotator Cuff Tears

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Postero-superior Rotator Cuff Tear

MRI, ultrasonographic explorations

Group Type EXPERIMENTAL

MRI

Intervention Type OTHER

MRI on both shoulder

ultrasonographic explorations

Intervention Type OTHER

ultrasound and elastography explorations on both shoulder

Healthy Postero-superior Rotator Cuff

MRI, ultrasonographic explorations

Group Type OTHER

MRI

Intervention Type OTHER

MRI on both shoulder

ultrasonographic explorations

Intervention Type OTHER

ultrasound and elastography explorations on both shoulder

Interventions

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MRI

MRI on both shoulder

Intervention Type OTHER

ultrasonographic explorations

ultrasound and elastography explorations on both shoulder

Intervention Type OTHER

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role collaborator

University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Tours

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Guillaume BACLE, PhD

Role: CONTACT

0234389444 ext. +33

Facility Contacts

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Guillaume BACLE, PhD

Role: primary

0234389444 ext. +33

Catherine ROUSSEL

Role: backup

0247479789 ext. +33

Other Identifiers

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DR190044

Identifier Type: -

Identifier Source: org_study_id

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