Finnish Imaging of Shoulder Trauma

NCT ID: NCT05800184

Last Updated: 2023-04-18

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

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-05

Study Completion Date

2025-12-31

Brief Summary

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The FIMAGE-Trauma study is an extension of the FIMAGE study and aims to answer the question if rotator cuff tears found on shoulder imaging after a shoulder injury are caused by the index trauma or are rather incidental findings. Eligible participants of the FIMAGE study will be invited to a follow up visit in the case of a shoulder injury or a sudden onset of significant shoulder symptoms (within a 2-year time frame). These findings will then be compared to the baseline data collected in the FIMAGE study (including the comparison of pre-injury and post-injury MRI:s)

Detailed Description

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Conditions

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Shoulder Pain Shoulder Injuries Rotator Cuff Tears Glenoid Labrum Tear

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Individuals with a shoulder injury

Individuals from a population based sample of 600 individuals aged 40 to 75 years that sustain a shoulder injury or a sudden onset of significant shoulder symptoms.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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Professor Teppo Järvinen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Helsinki University Central Hospital

Helsinki, , Finland

Site Status RECRUITING

Kuopio University Hospital

Kuopio, , Finland

Site Status NOT_YET_RECRUITING

Tampere University Hospital

Tampere, , Finland

Site Status NOT_YET_RECRUITING

Turku University Hospital

Turku, , Finland

Site Status NOT_YET_RECRUITING

Countries

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Finland

Central Contacts

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Thomas Ibounig, MD

Role: CONTACT

+358504286223

Saara Raatikainen

Role: CONTACT

Facility Contacts

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Thomas Ibounig, M.D.

Role: primary

+358504286223

Saara Raatikainen

Role: backup

Thomas Ibounig

Role: primary

Saara Raatikainen

Role: backup

Thomas Ibounig

Role: primary

Saara Raatikainen

Role: backup

Thomas Ibounig

Role: primary

Saara Raatikainen

Role: backup

Other Identifiers

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HUS/13603/2022

Identifier Type: -

Identifier Source: org_study_id

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