Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 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
排除标准
- •Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
- •Subjects implanted with non-MPO components (femoral stem, femoral head, acetabular liners) in the enrolled THA
- •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 or having pending incarceration
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 using Kaplan Meier analysis of all components at specified intervals out to 10 years follow-up. Measured by capturing date of revision or removal of the device.
次要结局
- Patient functional outcomes (hip specific)(Early (2-5 yrs), Midterm (5-7 yrs), and Long-term (10 yrs + 3 mos) beginning with first available follow-up interval)