Conservative Treatment vs Locked Plate Osteosynthesis for Proximal Humerus Fractures in the Elderly: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Sponsor
- University of Sao Paulo
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Individual relative Constant-Murley score
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Individual relative Constant-Murley score
Time Frame: 2 years
Constant-Murley score relative to the unaffected shoulder
Secondary Outcomes
- American Shoulder and Elbow Surgeons Shoulder (ASES) score(2 years)
- Constant-Murley score(2 years)
- Visual analog scale (VAS) for pain(2 years)
- Complication and reoperation rate(2 years)
- Rotator cuff ultrasound and magnetic resonance(2 years)
- 12-Item Short Form Health Survey (SF-12)(2 years)
- Radiographic evaluation(2 years)
Investigators
Mauro Gracitelli
PhD
University of Sao Paulo