Finnish Imaging of Shoulder Trauma

Recruiting

• Conditions: Rotator Cuff Tears; Glenoid Labrum Tear; Shoulder Pain; Shoulder Injuries

• Registration Number: NCT05800184
• Lead Sponsor: University of Helsinki

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-22
• Status Verified: 2023-04
• Study Start: 2023-04-05
• Study First Posted: 2023-04-05
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rotator Cuff Integrity on Shoulder Magnetic Resonance Imaging (MRI)	At baseline	Bilateral shoulder MRI comparing the integrity of the rotator cuff tendons on pre-injury and post-injury MRI scans. Each of the four rotator cuff tendons (supraspinatus, infraspinatus, teres minor, subscapularis) will be assessed and graded for structural changes (normal, tendinopathy, partial thickness tear, full thickness tear). The dimensions of full thickness tears will be measured and recorded (size in millimeters).
Constant -Murley Score	At baseline	The Constant-Murley Score was designed to assess the functional state of a shoulder and contains both physician- completed and patient-reported portions. The four domains include pain (15 possible points), activities of daily living (20 possible points), mobility (40 possible points), and strength (25 possible points). Scores range from 0 points (most disability) to 100 points (least disability).
Shoulder Pain and Disability Index (SPADI)	At baseline	Patient reported outcome measure. The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. A SPADI total score ranging from 0 (best) to 100 (worst) is produced by averaging the two subscale scores.

Secondary Outcome Measures

Name	Time	Method
Subjective Shoulder Value (SSV)	At baseline	The SSV score is defined as the subjective evaluation by the patient of shoulder function, expressed as a percentage of a normal shoulder. This score ranges from 0 to 100%.
Pain NRS	At baseline	The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".

Trial Locations

Locations (4)

Turku University Hospital; 🇫🇮 Turku, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Kuopio University Hospital; 🇫🇮 Kuopio, Finland