NCT04106674.
Study name | Two‐part proximal humerus ‐ conservative vs operative Official title: conservative versus operative treatment of two‐part proximal humerus fractures |
Methods | Single‐blind randomised controlled trial |
Participants | 50 participants, aged 60 to 85 years, with two‐part proximal humeral fractures (more than 50% displacement between head or shaft or 50° angulation of the head against the shaft in Y‐projection or more than 45° valgus or more than 30° varus of the Head Shaft Angle). |
Interventions | 1. Surgery: open reduction internal stabilisation. Implant choice pragmatic, surgeons' choice 2. Conservative treatment |
Outcomes | Follow‐up: 1 year Primary outcome: QuickDASH Secondary outcomes: Constant score, EQ‐5D, radiology, visual analogue scale score, number of participants with complications such as infection, avascular necrosis, failure of osteosynthesis, screw cut‐out, nerve damage, deep vein thrombosis |
Starting date | Start: 1 October 2019. Estimated study completion date: 31 October 2023 |
Contact information | Contacts: Annette Konstanse Bordewich Wikerøy, +004799717481 Email: awikeroy@hotmail.com |
Notes | Recruiting at Akershus University Hospital, Norway |