Finnish Imaging of Shoulder Trauma

NCT05800184 | Unknown

• 1 other identifier: HUS/13603/2022
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 4

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)

Conditions

Shoulder Pain; Shoulder Injuries; Rotator Cuff Tears; Glenoid Labrum Tear

Keywords

Shoulder; Injury; Rotator Cuff; Magnetic resonance Imaging

Outcome Measures

Primary Outcomes (3)

• Rotator Cuff Integrity on Shoulder Magnetic Resonance Imaging (MRI)

  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).

  At baseline

• Shoulder Pain and Disability Index (SPADI)

  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.

  At baseline

• Constant -Murley Score

  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).

  At baseline

Secondary Outcomes (2)

• Subjective Shoulder Value (SSV)

  At baseline

• Pain NRS

  At baseline

Other Outcomes (1)

• Clinical Shoulder Examination

  At baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects from a population based sample (FIMAGE study participants) who sustain a shoulder injury or sudden onset of significant shoulder symptoms within 2 years after the FIMAGE research visit.

You may qualify if:

• Ambulatory
• Participated in the FIMAGE
• Baseline MRI from FIMAGE study available

You may not qualify if:

• Contraindications to MRI
• Previous shoulder joint replacement
• Previous rotator cuff surgery

Sponsors & Collaborators

• University of Helsinki: lead
• Helsinki University Central Hospital: collaborator

Study Sites (4)

Helsinki University Central Hospital

Helsinki, Finland

RECRUITING

Kuopio University Hospital

Kuopio, Finland

NOT YET RECRUITING

Tampere University Hospital

Tampere, 33520, Finland

NOT YET RECRUITING

Turku University Hospital

Turku, Finland

NOT YET RECRUITING

MeSH Terms

Conditions

Shoulder Pain; Shoulder Injuries; Rotator Cuff Injuries; Wounds and Injuries

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rupture; Tendon Injuries

Central Study Contacts

Thomas Ibounig, MD

CONTACT

+358504286223; thomas.ibounig@helsinki.fi

Saara Raatikainen

CONTACT

saara.raatikainen@hus.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 5, 2023
• Study Start: April 5, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (4)