Rotator Cuff TearsVISUMIRNCT04223440
Ultrasonographic and MRI Explorations of Infraspinatus Muscle in Postero-superior Rotator Cuff Tear
A study testing MRI and ultrasonographic explorations in people with Rotator Cuff Tears, run by University Hospital, Tours at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- MRI and ultrasonographic explorations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2020to 19 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Rotator Cuff Tears
- Being tested
- MRI, ultrasonographic explorations
- Keywords
- Rotator Cuff Tears, MRI, Ultrasonographic explorations
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
MRI on both shoulder
ultrasonographic explorationsOther
ultrasound and elastography explorations on both shoulder
| Study group | Role | What they receive |
|---|---|---|
| Postero-superior Rotator Cuff Tear | Experimental | MRI, ultrasonographic explorations Receives: Other: MRI; Other: ultrasonographic explorations |
| Healthy Postero-superior Rotator Cuff | Other | MRI, ultrasonographic explorations Receives: Other: MRI; Other: ultrasonographic explorations |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI Texture Index (MTI)
MRI texture index (MTI) on the healthy side and pathological side
Measured: up to 2 months
Secondary outcomes (2)
Ultrasound Texture Index (UTI)
Ultrasound Texture Index (UTI) on the healthy side and pathological side
Measured: up to 2 months
velocity of shear wave in m.s-1
shear wave velocity on the healthy side and pathological side
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start24 Nov 2020
- Primary completion19 Mar 2021
- Study completion19 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223440
- Sponsor's protocol ID
- DR190044
- Acronym
- VISUMIR
- Status last verified
- Feb 2026
- First submitted
- 6 Jan 2020
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic and MRI Explorations of Infraspinatus Muscle in Postero-superior Rotator Cuff Tear
- ClinicalTrials.gov ID
- NCT04223440
- Acronym / sponsor ID
- VISUMIR / DR190044
- Conditions
- Rotator Cuff Tears
- Keywords
- Rotator Cuff Tears, MRI, Ultrasonographic explorations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postero-superior Rotator Cuff Tear | Experimental | Other: MRI, Other: ultrasonographic explorationsMRI, ultrasonographic explorations |
| Healthy Postero-superior Rotator Cuff | Other | Other: MRI, Other: ultrasonographic explorationsMRI, ultrasonographic explorations |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI on both shoulder | Other | Healthy Postero-superior Rotator Cuff, Postero-superior Rotator Cuff Tear |
| ultrasonographic explorationsultrasound and elastography explorations on both shoulder | Other | Healthy Postero-superior Rotator Cuff, Postero-superior Rotator Cuff Tear |
Primary outcome
MRI Texture Index (MTI)
Time frame: up to 2 months
MRI texture index (MTI) on the healthy side and pathological side
2 secondary outcomes
Ultrasound Texture Index (UTI)
Time frame: up to 2 months
velocity of shear wave in m.s-1
Time frame: up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Rotator Cuff Tears
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Voll Non-Degradable Shoulder Spacer FIH Study
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Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
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SMR Stemless Reverse vs SMR Reverse Shoulder System
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and ultrasonographic explorations in people with Rotator Cuff Tears, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI Texture Index (MTI) (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.