Comparing Nail versus Locking Plate in displaced three-part proximal humerus fractures; A multi-centre randomized controlled trial (Otago PHINZ trial) investigating the effect on function post-operatively. .

niversity of Otago-Christchurch0 sites214 target enrollmentMarch 16, 2023

Overview

No summary available.

Registry

who.int

Start Date

March 16, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Otago-Christchurch

•Patients above 18 years old with displaced three\-part proximal humerus fractures based on the Neer classification will be included. In three\-part fractures, either the lesser or greater tuberosity is displaced with associated displacement of the surgical neck producing a rotational deformity. Displaced fractures will be defined as a dislocation more than 1 cm or with an angle greater than 45° between head and diaphysis of humerus. The type of fractures will be classified according to the Neer\-classification.

•Exclusion criteria will be fractures extending to the humeral shaft or articular split, fractures more than 4 weeks old, or open fractures. Patients will be excluded if they are identified with concomitant ipsilateral fractures of distal humerus/or elbow joint, previous surgery of affected shoulder, pathologic fracture (i.e., malignancy fractures), neurovascular injuries (e.g., stroke or brachial plexus injuries), neurological disorders (e.g., Parkinson, or multiple sclerosis), or cognitive disorders (i.e., sever mental illness). Intra operative changes of treatment due to small diameter of humerus shaft, fracture line through the nail entry point or severely reduced bone quality resulting in fixation problems with either implants will be excluded.