Prospective Cohort Study of Proximal Humeral Fractures Treated With Targon® PH+
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Functional Capacity
研究概览
简要总结
With this study results of the Targon® PH+ nail, developed for the treatment of humeral head fractures, will be investigated clinically, radiological evaluation is optional. The primary objective of this study is to examine the effect of a plating treatment on the speed of recovery of functional capacity in adult patients. Secondary aims are to examine the level of pain, patient satisfaction, shoulder function, quality of life, radiological evaluation and complications.
Targon PH+ is CE certified. The study is a non-interventional cohort study sponsored by Aesculap
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •patients with a three- or four-fragment-fracture of the proximal humerus, with dislocation on X-ray
- •older than 60 years of age
- •written and signed patient consent
排除标准
- •Fractures more than 14 days old
- •multiple comorbidity
- •multitrauma (Injury Severity Score > 15)
- •prev. surgery on the injured shoulder
- •severely deranged function caused by a previous disease head-split proximal humerus fracture
- •combined humerus head and shaft fractures
- •pseudarthroses
- •crushed head cap of the humerus head (AO 11 C3 fractures)
- •isolated avulsion fracture of a tuberosity
- •unwillingness or inability to follow protocol instructions and study requirements (follow-up visits)
- •no signed informed consent
- •treatment not in line with Instructions for Use (IfU)
结局指标
主要结局
Functional Capacity
时间窗: 24 months
The DASH score (Disabilities of the Arm, Shoulder, and Hand) will be used to determine the recovery of functional capacity. It provides a summary of the responses on a scale of 0 (no disability) to 100 (severe disability)
次要结局
- Patient satisfaction(24 months)
- Radiological outcome (only if it could be raised in clinical standard)(24 months)
- Adverse Events(24 months)
- Level of pain(3, 12 and 24 months)
- Shoulder Function(12 months, 24 months)