Hemiarthroplasty versus Osteosynthesis in humeral fractures (HOMERUS): A Multicenter Randomized trial.

Rationale:

The optimal surgical management of three- and four-part proximal humeral fractures in elderly osteoporotic patients remains controversial. Mostly used techniques are hemiarthroplasty and angle stable locking compression osteosynthesis. In literature there is no evidence available showing advantage of angle stable locking compression plate osteosynthesis compared to hemiarthroplasty regarding speed of recovery of functional capacity, pain, patient satisfaction,functional outcome, quality of life, and complications.



Objective:

The objective of this study is to conduct a randomized controlled trial to compare hemiarthroplasty with open reduction and internal fixation with an angle stable locking compression plate in the treatment of dislocated three- and four-part fractures of the proximal humerus in the elder population. Primary outcome parameter is speed of recovery of functional capacity of the effected upper limb. We hypothesize that hemiarthroplasty shows quicker recovery of functional capacity. Secondary outcome parameters are pain,patient satisfaction, functional outcome, quality of life, radiographic evaluation and complications.



Study design:

A prospective, non-blinded, multicentric randomized controlled trial will be conducted to allocate patients to either hemiarthroplasty or open reduction and internal fixation with angle stable locking compression plate osteosynthesis to study speed of recovery of functional capacity and other secondary outcomes.



Study population:

Patients to be included suffer from three- or four- part fracture of the proximal humerus according to the Neer classification with more than 5 mm dislocation in one of the fracture-planes and are aged above 60 years. Patients with a fracture existing more than 14 days, ASA IV-V, multitrauma (ISS>16), pathological fracture, previous surgery on the injured shoulder, severely deranged function caused by a previous disease, head-split proximal humerus fracture and unwillingness or inability to follow instruction are excluded.



Intervention:

One group will be treated by hemiarthroplasty and the other group will be treated by open reposition and internal fixation with a angle stable locking compression plate.



Measurements:

In this study the following outcome parameters will be assessed: speed of recovery of functional capacity of the effected upper limb (primary outcome), pain, patient satisfaction, functional outcome, quality of life, radiographic evaluation and complications (secondary outcomes).

Hemiarthroplasty will show quicker recovery of functional capacity of the affected upper limb in 2 years compared with open reduction and internal fixation with an angle stable locking compression plate in the treatment of dislocated three and four part fractures of the proximal humerus.

Baseline, 3 months, 6 months, 9 months, 12 months, 24 months.

1. Hemiarthroplasty;

2. Angle stable locking compression plate osteosynthesis.