Comparing Nail versus Locking Plate in patients with displaced three-part proximal humerus fractures; A randomized controlled pilot trial (PHINZ trial) investigating the feasibility of a definitive RCT.

niversity of Otago-Christchurch0 sites13 target enrollmentSeptember 27, 2023

Overview

No summary available.

Registry

who.int

Start Date

September 27, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

niversity of Otago-Christchurch

•Patients with displaced three\-part proximal humerus fractures based on 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.

•1\) Fractures extending to the humeral shaft
•2\) Articular split,
•3\) fractures more than 4 weeks old,
•4\) open fractures.
•5\) Concomitant ipsilateral fractures of distal humerus/ or elbow joint,
•6\) Previous surgery of affected shoulder,
•7\) Pathologic fracture (malignancy fractures),
•8\) Neurovascular injuries (e.g., stroke, or brachial plexus injuries),
•9\) Neurological disorders (e.g., Parkinson, or multiple sclerosis) or cognitive disorders (i.e., sever mental illness).
•10\) Intra operative changes of treatment due to small diameter of humerus shaft to use nail, fracture line through the nail entry point or severely reduced bone quality resulting in fixation problems with either implants.