A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of Clavicle Plates
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- To assess a change in Veterans Rand 12-Item Health Survey (VR-12)
研究概览
简要总结
The objective of the registry is to evaluate the continued safety and performance of Arthrex Clavicle Plates used to treat clavicle fractures.
详细描述
To assess safety, device-related adverse events will be reported and evaluated over the course of the study. To evaluate the performance imaging of the target area will be evaluated at three months postoperative. Additionally, patient-reported outcomes will be evaluated at three months postoperative, 6 months postoperative, and one year postoperative using the Visual Analogue Scale (VAS), Veterans Rand 12-Item Health Survey (VR-12), and American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject requires surgery using the Arthrex Clavicle Plate for clavicle fracture.
- •The subject is 18 years of age or over.
- •The subject is not considered a vulnerable subject (i.e., child, pregnant, nursing, prisoner, or ward of the state).
- •Subject signed informed consent and is willing and able to comply with all study requirements
排除标准
- •Insufficient quantity or quality of bone.
- •Blood supply limitations and previous infections, which may retard healing.
- •Foreign-body sensitivity.
- •Any active infection or blood supply limitations.
- •Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
- •Subjects that are skeletally immature.
结局指标
主要结局
To assess a change in Veterans Rand 12-Item Health Survey (VR-12)
时间窗: Preoperatively, 3 months, 6 months and 12 months postoperatively
Patient reported changes in general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring scores up
To assess a change in American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
时间窗: Preoperatively, 3 months, 6 months and 12 months postoperatively
ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points.
To assess a change in Visual Analogue Scale (VAS) survey
时间窗: Preoperatively, 3 months, 6 months and 12 months postoperatively
Patient reported pain scale 0-10 point scale (0 min,10 max)
次要结局
未报告次要终点