Study period | |||||||
Enrolment | Allocation | Postallocation | |||||
Time point | Within 10 days after trauma | Within 10 days after trauma | Within 14 days after trauma | 6 weeks | 12 weeks | 6 months | 12 months |
Enrolment: | |||||||
Eligibility screen | X | ||||||
Informed consent | X | ||||||
Allocation | X | ||||||
Interventions: | |||||||
ORIF | X | ||||||
Bracing | |||||||
Assessments: | |||||||
Baseline data, 15D, DASH | X | X | |||||
Assessment for recovery,* DASH, pain-NRS, 15D | X | X | X | X | |||
Constant Score, patient questionnaire, X-ray | X | X | X | X |
*See text for definition of recovery in this trial.
DASH, Disabilities of Arm, Shoulder and Hand; NRS, Numerical Rating Scale; ORIF, open reduction and internal fixation.