Diaphyseal Fractures of the Humerus: A Prospective Cohort Study Comparing the Conservative Treatment and the Surgical Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 4
- 主要终点
- Function and quality of life on DASH scale
研究概览
简要总结
The fracture of the humeral diaphysis is a condition that represents 2% of all fractures. The conservative treatment of diaphyseal fractures of the humerus has long been considered the only option and the surgical treatment was primarily reserved for displaced fractures with no contact of bone ends. However, for a few years there has been an upsurge of indications for the surgical treatment of diaphyseal fractures.
The purpose of this study is to compare the functional outcomes and the quality of life of surgically treated patients versus those who undergo a conservative treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female over 18 years
- •Fracture of the humeral diaphysis
- •Recent fracture (14 days or less)
- •Closed fracture
- •Signing of consent form
排除标准
- •Segmental fracture of the humerus
- •Fracture with proximal or distal intra articular extension
- •Open fracture
- •Polytrauma
- •Floating elbow or shoulder
- •Pathological fracture
- •Simultaneous fracture of both humerus
- •Associated vascular disease
- •Severe neuromuscular disorders such as Parkinson, hemiparesis, myasthenia gravis, muscular dystrophy, etc. ...
- •medical contraindication to surgery
- •severe central neurological disease disabling patient to fill in questionnaires (senile dementia, Alzheimer's, etc ...
- •Male or female unable to consent
- •Any other condition which prevents the assessor from fully monitoring the patient during study
结局指标
主要结局
Function and quality of life on DASH scale
时间窗: 6 months after treatment
The function and quality of life are measured using the DASH scale six months after treatment.
次要结局
- DASH score(12 months after treatment)
- Return to professional activities(3 months after treatment)
- SF-36 score(12 months after treatment)
- Proportion of additional surgeries(12 months after surgery)
- Radiological loss of reduction(6 months after treatment)
- Union rate(6 months after treatment)
- Rates of complication(within the first year following treatment)
- Pain on visual analogue pain scale (VAS)(2 weeks after treatment)
- Pain on VAS(12 months after treatment)
- Measurement of range of motion of the shoulder(12 months after treatment)
- Measurement of range of motion of the elbow(12 months after treatment)
研究者
Pelet Stephane
Dr Stephane Pelet MD, PhD Orthopedic surgeon
Hopital de l'Enfant-Jesus