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. 2022 Jun 21;2022(6):CD000434. doi: 10.1002/14651858.CD000434.pub5

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)