NCT02314611终止不适用
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator HA Coated Modular Femoral Stems
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Component Survivorship
研究概览
简要总结
MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing components marketed in the European Union (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 the medial device directives (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
- •Subject has undergone primary THA for any of the following:
- •Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;
- •Inflammatory degenerative joint disease such as rheumatoid arthritis; or
- •Correction of functional deformity
- •Subject is implanted with the specified combination of components
- •Subject is willing and able to complete required study visits or assessments
- •Previously implanted bilateral subjects can have both THAs enrolled in the study provided: 1) the specified combination of components were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Investigator Agreement, and 4) the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrollment of a previously unimplanted hip is not permitted in this study.
排除标准
- •Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
- •Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
- •Subjects unwilling to sign the Informed Consent document
- •Subjects with substance abuse issues
- •Subjects who are incarcerated
结局指标
主要结局
Component Survivorship
时间窗: 10 years post-operative
The primary objective of this study is to estimate survivorship of all components at specified intervals out to 10 years follow-up.
次要结局
- Patient functional outcomes (hip specific)(5 months, 1, 2, 5, 7, and 10 years beginning with first available follow-up interval)
- Patient functional outcomes (quality of life)(5 months, 1, 2, 5, 7, and 10 years beginning with first available follow-up interval)
研究者
研究点 (1)
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