A multicentre multinational RCT to investigate whether non-surgical treatment is non-inferior to surgical treatment for displaced extraarticular lateral clavicle fractures in adults.
The aim of this study is to investigate whether non-surgical treatment is non inferior to surgical treatment for displaced lateral clavicle fractures with regards to functional outcome measured with different patient-reported outcome measures. Patients aged 18-65 years will be randomized to non-surgical or surgical (pragmatic) treatment. The primary outcome is the Disabilities of Arm Hand and Shoulder (DASH) score at 1 year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Non-surgical treatment with a simple sling and physiotherapy according to standardized program.
Surgical treatment with plate and screws (lateral clavicle plate, clavicle plate or hook plate with/without coracoclavicular fixation).
Odense University Hospital
Odense, Denmark
NOT_YET_RECRUITINGTampere University Hospital
Tampere, Finland
NOT_YET_RECRUITINGØstfold Hospital Trust
Fredrikstad, Norway
Disabilites of the Arm, Shoulder and Hand (DASH)
A 30-item patient-reported outcome measure concerning shoulder, arm and hand function, with two additional 4-item modules concerning work and sports function. Min: 0 Max: 100. 0 representing no disability and 100 representing the most severe disability. A DASH score of 50 or more is often considered a cutoff for the presence of severe disability, while 20 or more suggests a medium level of disability.
Time frame: 1 year
Disabilites of the Arm, Shoulder and Hand (DASH)
A 30-item patient-reported outcome measure concerning shoulder, arm and hand function, with two additional 4-item modules concerning work and sports function. Min: 0 Max: 100 0 representing no disability and 100 representing the most severe disability. A DASH score of 50 or more is often considered a cutoff for the presence of severe disability, while 20 or more suggests a medium level of disability.
Time frame: Pre-injury, 6 weeks, 3 months, 6 months, 2 years, 5 years
Nottingham Clavicle Score (NCS)
A 10-item disease-specific PROM concerning functional outcome after injuries and diseases around the clavicle. The minimum possible score is 20, and the maximum is 100. A higher score indicates better functional ability, while a lower score suggests greater functional disability. The NCS can be graded as excellent (80-100), good (60-79), fair (40-59), or poor (\<40).
Time frame: 6 weeks, 3 months, 6 months, 1, 2, 5 years
University of California, Los Angeles (UCLA) Activity scale
An activity scale measured in 10 levels. It ranges from 1 to 10, with 1 representing no physical activity and 10 representing regular participation in impact sports.
Time frame: Pre-injury, 6 weeks, 3 months, 6 months, 1 years
EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
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Kalmar Regional Hospital
Kalmar, Sweden
RECRUITINGLinköping University Hospital
Linköping, Sweden
RECRUITINGSkane University Hospital
Malmo, Sweden
RECRUITINGÖrebro University Hospital
Örebro, Sweden
RECRUITINGDanderyd Hospital
Stockholm, Sweden
RECRUITINGStockholm South Hospital
Stockholm, Sweden
RECRUITINGNorrlands University Hospital
Umeå, Sweden
RECRUITING...and 1 more locations
Health-Related Quality of Life (HRQoL) measured in 5 Levels. The minimum and maximum possible outcomes for EQ-5D-5L index scores are -0.573 and 1, respectively. The minimum value represents a health state considered worse than death, while 1 represents full health.
Time frame: Pre-injury, 6 weeks, 3 months, 6 months, 1, 2, 5 years
Visual Analog Scale (VAS) for pain
Pain measure by visual analog scale in 11 levels. Minimum 0 and maximum 10. Higher figure indicates more pain. 10 is maximum pain.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2, 5 years