A Randomized Clinical Trail Comparing a Lateral Minimally Invasive Approach and the Traditional Anterior Approach for Plating of Proximal Humerus Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Quick DASH
研究概览
简要总结
A prospective randomized clinical trial is proposed to compare the plate fixation of proximal humerus fractures using a minimally invasive lateral approach and the traditional anterior approach.Forty five patients will be assigned to each approach (total of 90 patients) and will be assessed 7 times over a two-year period. The trial's primary objectives will be to demonstrate the efficacy of the plating technique in terms of speed of recuperation of function. The Quick DASH will be used for evaluation of function.The study will also examine secondary end-points of pain, range of motion, esthetic satisfaction and radiographic outcome, as assessed by the components of the Constant Score3,4, SF-12V2 Questionnaire, and Patient Scare Assessment Scale Questionnaire. Furthermore, the assessment of safety will be based on the rates of all reported complications and adverse events at 2 years
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Humeral surgical neck fracture, Neer II valgus-type Neer III
- •Patient willing to participate in the study
- •Patient available for follow-up through at least two years
- •Patient with acceptable preoperative medical clearance and free of, or treated for, medical conditions that would pose excessive operative risk
- •Patient fluent in French and/or English and able to understand his/her role in the study
排除标准
- •Inflammatory arthritis
- •Prior shoulder pathology
- •Active local or systemic infection
- •Neurologic or musculoskeletal disease that may adversely affect mobility
- •Participation in any other pharmaceutical, biologic or medical-device clinical investigation
- •Severe documented psychiatric disease
- •Severe ipsilateral elbow or wrist disease
- •Fracture resistant to reduction attempts through the minimally invasive lateral approach
结局指标
主要结局
Quick DASH
时间窗: 3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.
次要结局
- SF-12V2 Questionnaire Constant Shoulder Score The Patient Scar Assessment Scale Complication rate(3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.)
研究者
Dominique Rouleau
Orthopaedic surgeon
Université de Montréal