NCT02314702进行中（未招募）不适用
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of participants who require a revision
研究概览
简要总结
MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU. These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has undergone revision total hip arthroplasty
- •Subject is implanted with the specified combination of components
- •Subject is willing and able to complete required study visits or assessments
排除标准
- •Subjects currently enrolled in another clinical study
- •Subjects unwilling to sign the Informed Consent document
- •Subjects with substance abuse issues
- •Subjects who are incarcerated or have pending incarceration
结局指标
主要结局
Number of participants who require a revision
时间窗: 10 years post-operative
The primary objective of this study is to estimate the revision rate of all components at specified intervals out to 10 years follow-up.
次要结局
- Patient functional score on the the Oxford Hip Score instrument(Screening (First Available), 2-5 years, 5-7 years, and 10 years)
- Patient functional score on the EQ-5D-3L instrument(Screening (First Available), 2-5 years, 5-7 years, and 10 years)
研究者
研究点 (1)
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