Investigating the causes of rotator cuff tears after shoulder injuries
Finnish Imaging of Shoulder Trauma
University of Helsinki · NCT05800184
This study is trying to find out if rotator cuff tears seen on scans after a shoulder injury are caused by the injury or just happened by chance in people who had shoulder problems in the last two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | University of Helsinki (other) |
| Locations | 4 sites (Helsinki and 3 other locations) |
| Trial ID | NCT05800184 on ClinicalTrials.gov |
What this trial studies
The FIMAGE-Trauma study aims to determine whether rotator cuff tears identified through imaging after a shoulder injury are a result of the injury itself or merely incidental findings. Participants who were part of the original FIMAGE study and have experienced a shoulder injury or sudden onset of significant shoulder symptoms within two years will be invited for follow-up. Their imaging results will be compared to baseline data collected during the FIMAGE study, including pre-injury and post-injury MRI scans. This observational study will help clarify the relationship between shoulder trauma and rotator cuff injuries.
Who should consider this trial
Good fit: Ideal candidates are individuals who have previously participated in the FIMAGE study and have experienced a recent shoulder injury or significant shoulder symptoms.
Not a fit: Patients with contraindications to MRI or those who have had previous shoulder joint replacement or rotator cuff surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding of shoulder injuries and lead to better diagnostic and treatment strategies for patients.
How similar studies have performed: While this study builds on previous findings from the FIMAGE study, the specific focus on the causation of rotator cuff tears post-injury is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ambulatory * Participated in the FIMAGE * Baseline MRI from FIMAGE study available Exclusion Criteria: * Contraindications to MRI * Previous shoulder joint replacement * Previous rotator cuff surgery
Where this trial is running
Helsinki and 3 other locations
- Helsinki University Central Hospital — Helsinki, Finland (RECRUITING)
- Kuopio University Hospital — Kuopio, Finland (NOT_YET_RECRUITING)
- Tampere University Hospital — Tampere, Finland (NOT_YET_RECRUITING)
- Turku University Hospital — Turku, Finland (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Thomas Ibounig, MD
- Email: thomas.ibounig@helsinki.fi
- Phone: +358504286223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Shoulder Pain, Shoulder Injuries, Rotator Cuff Tears, Glenoid Labrum Tear, Shoulder, Injury, Rotator Cuff, Magnetic resonance Imaging