Conservative Treatment of Proximal Humeral Fractures - Immobilization for 1 Week Compared to Three Weeks: Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- pain (analogical pain scale)
研究概览
简要总结
Optimal treatment of proximal humeral fractures is yet to be defined. Many of them can be treated non-operatively. The question remains on how long do we have to immobilize non-operatively treated proximal humeral fractures?
详细描述
There is still controversy on best treatment of proximal humeral fractures. While some authors propose surgical treatment other advocate for conservative treatment. Traditionally, fractures treated non-operatively undergo a 3-week period of immobilization followed by progressive rehabilitation program. Nevertheless, there is little evidence to support a 3-week immobilization period. The purpose of this study is to bring evidence to support either a 1-week immobilization or 3-week immobilization period in non-operatively treated proximal humeral fractures.
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
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 60 yo and < 85 yo
- •Acute fractures less than 1 week evolution
- •Conservative treatment decided by orthopedic surgeon
- •Contact between humeral head and humeral shaft.
- •No gleno-humeral dislocation
- •No previous surgery
排除标准
- •Cognitive impairment
研究组 & 干预措施
1-week
patients undergoing 1-week immobilization period
干预措施: conservative treatment (Procedure)
3-week
patients undergoing 3-week immobilization period
干预措施: conservative treatment (Procedure)
结局指标
主要结局
pain (analogical pain scale)
时间窗: 1 year
pain assessment through all the follow-up through the analogical pain scale
次要结局
- fragment displacement assessed through X-Ray exam(3 months)
- functional outcome(1 year)
研究者
Carlos Torrens
Medical Doctor
Hospital del Mar