DRKS00019061Enrolling By Invitation不适用
Ottobock Outcome Registry - International post-marketing prospective observational evaluation of routine prosthetic patient care of lower limb amputees - Ottobock Outcome Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 5,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- one 至 one（—）
- 性别
- All
入选标准
- •Subject is unilateral or bilateral lower limb amputee.
- •Subject will be fitted with a new prosthesis, or at least one major component of their original prosthesis is being replaced.
- •Subject will be fitted by a CPO from the prosthetic clinics partici-pating in the study.
- •Subject is willing and able to independently provide informed consent. In case of underage subjects, the informed consent should be provided in accordance with the local regulations either by subject or their legal representative.
- •Subject is willing and able to answer the questionnaires.
排除标准
- •Subject is unwilling/unable to follow instructions.
- •Subject cannot provide inform consent.
- •Subject is unwilling/unable to answer the questionnaires.
- •The expected mobility level of the subject after the fitting is K0 ac-cording to the Medicare Functional Classification Level (MFCL)
研究者
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