Conservative Treatment vs Locked Plate Osteosynthesis for Proximal Humerus Fractures in the Elderly: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Individual relative Constant-Murley score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Locking plate
Surgical treatment with open reduction and osteosynthesis with locking plate
干预措施: Osteosynthesis with locking plate (Procedure)
Conservative
Conservative treatment with sling and rehabilitation
干预措施: Sling (Procedure)
结局指标
主要结局
Individual relative Constant-Murley score
时间窗: 2 years
Constant-Murley score relative to the unaffected shoulder
次要结局
- 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)
研究者
Mauro Gracitelli
PhD
University of Sao Paulo