NCT01650064已完成不适用
Latin America Hip Fracture Mortality Study
AO Clinical Investigation and Publishing Documentation16 个研究点 分布在 8 个国家目标入组 168 人开始时间: 2013年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 16
- 主要终点
- Death
研究概览
简要总结
The purpose of this study is to estimate the survival proportion one year after surgery for intertrochanteric fracture in older adults in Latin America.
详细描述
This is a multi-center, prospective, observational clinical study to evaluate mortality in patients with surgically-treated hip fracture in Latin America, and investigate associated prognostic factors. Patients will be followed for 12 months.
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 60 years and older
- •Diagnosis of an isolated intertrochanteric fracture (AO 31-A) confirmed by radiographic evaluation
- •Primary surgical fracture treatment within 10 days after trauma
- •No prior treatment for the fracture
- •Ability to understand the content of the patient information / informed consent form
- •Willingness and ability to participate in the clinical investigation according to the CIP
- •Signed and dated IRB/EC-approved written informed consent
排除标准
- •Polytrauma (ie, multiple injuries, whereof one or the combination of several injuries is life threatening)
- •Pathologic fracture due to a disease other than osteoporosis (eg, tumor, metastasis)
- •Active malignancy
- •Class 5 and 6 of the American Society of Anesthesiologists (ASA) physical status classification (Appendix 2)
- •Neurological and/or psychiatric disorders that would preclude reliable assessment (eg, Parkinson's disease, multiple sclerosis, severe depression)
- •Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
- •Noncompletion of patient baseline questionnaires
- •Prior implant on the fractured hip
结局指标
主要结局
Death
时间窗: after 1 year
次要结局
- EQ-5D(Screening/Preoperative, 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days)
- Wound healing(30±7 days, 60±14 days, and 90± 21 days)
- Parker Mobility Score(Screening/Preoperative, 30±7 days, 60±14 days, 90± 21 days, 365 (up to 425) days)
- Anticipated surgical treatment-related adverse events(Postoperative (2 to 5 days), 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days)
- Harris Hip Score(Screening/Preoperative and 90 ± 21 days)
- Fracture healing(60±14 days and 90± 21 days)
研究者
研究点 (16)
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