Table I.

Proximal fracture of the humerus evaluation by randomisation (PROFHER) inclusion and exclusion criteria

PROFHER trial
Inclusion criteria
Adults (aged 16 or above) presenting within three weeks of their injury with a radiologically confirmed displaced fracture of the humerus involving the surgical neck. This should include all two-part surgical neck fractures, as well as three-part (including surgical neck) and four-part fractures of the proximal humerus (Neer Classification). It may also include displaced surgical neck fractures that do not meet the exact displacement criteria of the Neer classification (> 1 cm or/and 45° angulation of displaced parts) where this reflects an individual surgeon’s equipoise (i.e., whether or not the surgical neck fracture should be treated surgically).
Exclusion criteria
Associated dislocation of the injured shoulder joint
Open fracture
Mentally incompetent patient: unable to understand trial procedure or instructions for rehabilitation; significant mental impairment that would preclude compliance with rehabilitation and treatment advice
Comorbidities precluding surgery/anaesthesia
A clear indication for surgery such as severe soft-tissue compromise requiring surgery/emergency treatment (nerve injury/dysfunction)
Multiple injuries: same limb fractures; other upper limb fractures
Pathological fractures (other than osteoporotic) and terminal illness
Participant not resident in trauma centre catchment area