NCT05553535

Brief Summary

Conventional radiographs are still considered the reference for identifying rotator cuff calcific tendinosis. MRI is widely performed for rotator cuff disorders evaluation but has a moderate accuracy in rotator cuff calcific tendinosis diagnosis and calcific deposits identification (sensitivity and specificity around 60%), even though it helps in determining acuity of the finding by adjacent soft tissue edema depiction and differential diagnosis identification (i.e. adhesive capsulitis, sub-acromial bursitis…). Zero echo time (ZTE) MRI provides enhanced bone contrast by enabling the acquisition of signals from tissues exhibiting the shortest T2 values on a single sequence with a spatial resolution of 0.8-1.2 mm isotropic and can therefore provide images similar to those obtained with radiographs. We hypothesize that ZTE images could also depict rotator cuff calcific tendinosis, but to our knowledge, no study compared this technique to radiographs and/or standard MRI.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

Same day

First QC Date

September 19, 2022

Last Update Submit

September 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • calcific deposits presence

    presence of signal hyperintensity within the tendon on MRI ZTE sequence

    Retrospective review of all MRI scans, performed at a maximum of 1 year before the reading, during two reading sessions, with an interval of 15 days, in october and november 2022

Study Arms (2)

cases

cases of rotator cuff calcific tendinosis on imaging studies

Diagnostic Test: MRI

witnesses

differential diagnosis or normal cases

Diagnostic Test: MRI

Interventions

MRIDIAGNOSTIC_TEST

retrospective review of shoulder MRI

caseswitnesses

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients over 18 years old referred to our department for a suspicion of rotator cuff tendinosis

You may qualify if:

  • patient referred to the imaging department for a MRI scan in case of suspicion of rotator cuff tendinosis

You may not qualify if:

  • incomplete data sets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Norenberg D, Ebersberger HU, Walter T, Ockert B, Knobloch G, Diederichs G, Hamm B, Makowski MR. Diagnosis of Calcific Tendonitis of the Rotator Cuff by Using Susceptibility-weighted MR Imaging. Radiology. 2016 Feb;278(2):475-84. doi: 10.1148/radiol.2015150034. Epub 2015 Sep 3.

    PMID: 26347995BACKGROUND
  • Aydingoz U, Yildiz AE, Ergen FB. Zero Echo Time Musculoskeletal MRI: Technique, Optimization, Applications, and Pitfalls. Radiographics. 2022 Sep-Oct;42(5):1398-1414. doi: 10.1148/rg.220029. Epub 2022 Jul 29.

    PMID: 35904982BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Central Study Contacts

romain gillet, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 19, 2022

First Posted

September 23, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share