Study period | ||||
Preallocation | Allocation | Postallocation | ||
Enrolment | Baseline | Days 10–14 | Months 6 and 12 | |
Timepoint | -t | t0 | 0 | t1 and t2 |
Enrolment | ||||
Eligibility screening | x | |||
Informed consent | x | |||
Allocation | x | |||
Intervention | ||||
Intervention (advice) | ||||
Comparator (advice +rehabilitation care) | ||||
Assessments | ||||
Age, sex, fracture type | x | |||
Primary outcome measure | ||||
Oxford shoulder score, 0–48 | x | |||
Secondary self-reported outcomes | ||||
EQ-5D-3L <0–1 | x | |||
Fracture-related adverse events/complications | x | |||
Conversion to surgery (failure in both groups) | x |
EQ-5D-3L, European Quality of life-5 Dimensions-Three-Level