Shoulder Fractures Clinical Trial
Official title:
Conservative Treatment vs Locked Plate Osteosynthesis for Proximal Humerus Fractures in the Elderly: a Randomized Controlled Trial
This is a randomized trial comparing conservative with surgical treatment (with open reduction and locking plate fixation) for proximal humeral fractures in patients aged more than 60 years.
Different methods have been used in the treatment of proximal humeral fractures. Usually,
treatment choice depends on fracture displacement, patient age, osteoporosis, and other
characteristics. Locking plate fixation has become the most widely used method among surgical
techniques, while partial arthroplasty is reserved for older patients and comminuted
articular fractures. Generally, nonsurgical treatment involves a brief period with sling
immobilization and physiotherapy rehabilitation.
A recent multicenter study showed no difference between conservative and surgical treatments,
including internal fixation with locking plates. Two other randomized studies showed mixed
results, with no relevant clinical differences between the methods. No previous trial has
evaluated the quality of reduction in surgically treated fractures and its relation to
outcomes. Our study aims to compare both techniques with a detailed radiographic and
tomographic evaluation, in elderly patients. We also aim to evaluate the influence of
reduction and plate positioning on clinical outcomes. This is a single center trial, in which
surgeries will be performed by only two experienced surgeons.
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