NCT02944058.
| Study name | Plate fixation versus intramedullary nailing of 3 and 4 part proximal humerus fractures |
| Methods | Randomised controlled trial |
| Participants | 90 participants (target) aged 18 or over with 3‐ and 4‐part proximal humeral fractures |
| Interventions | 1. PHILOS plate
2. Multiloc intramedullary nail Deltopectoral or deltoid split as surgical access. All participants will have calcar screws and cuff sutures |
| Outcomes | Follow‐up: 6, 12, 52 and 104 weeks, but also 5 years Primary outcome: DASH (QuickDASH at 6 weeks) Secondary outcomes: Constant score; radiologically‐assessed complications (plate cut‐out, nail migration, screw cut‐out, reduction of head shaft angle / varus subsidence); complications (infection, avascular necrosis, thrombosis, nerve compression or damage, pseudoarthrosis); economics (visits to doctor, physiotherapist, sick leave, reoperations) |
| Starting date | October 2016 Study completion: October 2025 |
| Contact information | Dr Annette KB Wikerøy, University Hospital, Akershus, Norway Email: awikeroy@hotmail.com |
| Notes | Status: recruiting (July 2018) |