NCT03328650招募中不适用
Clinical Outcomes of the ALPS Proximal Humerus Plating System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Bone Material Strength
研究概览
简要总结
The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System.
Specific Aims:
- Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs
- Obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions
- Document revisions, complications, and adverse events
详细描述
The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System.
Specific Aims:
- Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs
- Obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions
- Document revisions, complications, and adverse events
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
- •Patients who present with a proximal humerus fracture requiring primary or revision ORIF using A.L.P.S Proximal Humerus Plating System
- •Patients who present with a proximal humerus fracture that involves the metaphysis
- •18 years or older
排除标准
- •Patients under the age of 18
- •Patients who have an infection, sepsis, or osteomyelitis
- •Patients who are unwilling to take part in study, have documented psychiatric disorder that limits ability to consent and maintain follow-up, or who may have severe problems maintaining follow-up (e.g. patients who are prisoners, homeless, intellectually changed without adequate family support)
- •Patients who do not speak English (do to unavailability of non-English surveys)
- •Patients who have known risk factors of pathologic fractures (e.g. bone metastasis)
- •Patients who have received treatment for osteoporosis (e.g. bisphosphonate) within the last 5 years or whose treatment lasted longer than 5 years
- •Patients who have Type 1 diabetes
- •Patients who have other bone disease (e.g. osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism)
- •Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use
结局指标
主要结局
Bone Material Strength
时间窗: During surgical procedure
Measured by the Osteoprobe
Bone Indentation Distance
时间窗: During surgical procedure
Measured by the Osteoprobe
次要结局
未报告次要终点
研究者
Mihir Desai
Assistant Professor of Orthopaedic Surgery and Rehabilitation
Vanderbilt University Medical Center
研究点 (2)
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