Shoulder Fractures
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREOsteosynthesis with locking plate
Open reduction and osteosynthesis with locking plate
PROCEDURESling
Conservative treatment with sling and rehabilitation
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Proximal humeral fractures, involving humeral head, with at least one of the following parameters: * Head-shaft angle between 100-200° or \>175° on coronal plane; * Shaft translation (on coronal or sagittal plane) \> 1cm; * Tuberosity displacement \> 0,5cm; * Head shaft angulation \>45° in axial or sagittal plane; * Less then 30 days
Exclusion criteria
* No contact between shaft and humeral head * Head-shaft angle \<100° on coronal plane * Articular head fracture with displacement \> 2mm * Fracture-dislocation * Bilateral fracture * Open fracture * Ipsilateral or contralateral superior limb fracture * Pathological fracture (tumors or bone disease, except for osteoporosis) * Previous rotator cuff complete tear * Previous infection * Neurological injury * Previous shoulder surgery * Inability to answer subjective scores
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Individual relative Constant-Murley score | 2 years | Constant-Murley score relative to the unaffected shoulder |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Constant-Murley score | 2 years | — |
| 12-Item Short Form Health Survey (SF-12) | 2 years | Quality of life evaluation |
| Visual analog scale (VAS) for pain | 2 years | — |
| American Shoulder and Elbow Surgeons Shoulder (ASES) score | 2 years | Subjective functional evaluation |
| Radiographic evaluation | 2 years | Union, head-shaft angle, tuberosities reduction, medial support and Fjalestad reduction criteria |
| Rotator cuff ultrasound and magnetic resonance | 2 years | — |
| Complication and reoperation rate | 2 years | — |
Countries
Brazil
Outcome results
None listed