Clavicle Fracture
Conditions
Keywords
Displaced lateral clavicle fracture, Non-surgical, Surgical, PROMs, Health economy, Non-inferior, Complications
Brief summary
A multicentre multinational RCT to investigate whether non-surgical treatment is non-inferior to surgical treatment for displaced extraarticular lateral clavicle fractures in adults.
Detailed description
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.
Interventions
PROCEDURESimple Sling and Physiotherapy
Non-surgical treatment with a simple sling and physiotherapy according to standardized program.
PROCEDURESurgical treatment
Surgical treatment with plate and screws (lateral clavicle plate, clavicle plate or hook plate with/without coracoclavicular fixation).
Sponsors
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallell with cross-over option in non-surgical arm
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
\- Displaced extraarticular lateral clavicle fracture (type II or V according to the modified Neer classification)
Exclusion criteria
* Pathological fracture * Open fracture * Neurovascular injury * Same-time fracture in the upper extremity * Polytrauma * Contraindications to surgery and/or anesthesia * Unable to give informed consent * Inability to complete follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disabilites of the Arm, Shoulder and Hand (DASH) | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disabilites of the Arm, Shoulder and Hand (DASH) | Pre-injury, 6 weeks, 3 months, 6 months, 2 years, 5 years | 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. |
| Nottingham Clavicle Score (NCS) | 6 weeks, 3 months, 6 months, 1, 2, 5 years | 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). |
| University of California, Los Angeles (UCLA) Activity scale | Pre-injury, 6 weeks, 3 months, 6 months, 1 years | 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. |
| EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire | Pre-injury, 6 weeks, 3 months, 6 months, 1, 2, 5 years | 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. |
| Visual Analog Scale (VAS) for pain | Baseline, 6 weeks, 3 months, 6 months, 1, 2, 5 years | Pain measure by visual analog scale in 11 levels. Minimum 0 and maximum 10. Higher figure indicates more pain. 10 is maximum pain. |
Countries
Denmark, Finland, Norway, Sweden
Contacts
Primary ContactPontus Christersson, MD, PhD Student
Outcome results
None listed