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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
58
Open reduction and osteosynthesis with locking plate
Conservative treatment with sling and rehabilitation
University of Sao Paulo - Department of Orthopedics and Traumatology
São Paulo, Brazil
RECRUITINGIndividual relative Constant-Murley score
Constant-Murley score relative to the unaffected shoulder
Time frame: 2 years
American Shoulder and Elbow Surgeons Shoulder (ASES) score
Subjective functional evaluation
Time frame: 2 years
Constant-Murley score
Time frame: 2 years
12-Item Short Form Health Survey (SF-12)
Quality of life evaluation
Time frame: 2 years
Visual analog scale (VAS) for pain
Time frame: 2 years
Complication and reoperation rate
Time frame: 2 years
Radiographic evaluation
Union, head-shaft angle, tuberosities reduction, medial support and Fjalestad reduction criteria
Time frame: 2 years
Rotator cuff ultrasound and magnetic resonance
Time frame: 2 years
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