Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Component Survivorship
研究概览
简要总结
Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) marketed in the European Union (EU) . These types of studies are required by regulatory authorities for all THA devices that do not have 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.
详细描述
Total hip arthroplasty (THA) has been performed since the early 1920s and is generally considered to be one of the most successful orthopedic surgeries performed. The 8th Annual Report from the National Joint Registry of England and Wales reported 95.3% component survivorship at 7 years for over 300,000 THA implantations. MicroPort Orthopedics, Inc. (MPO) currently markets several THA components throughout the world, including the European Union (EU). As part of the process for gaining approval to market in the EU, MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of these THA components. The objectives of this study are to evaluate component survivorship and total functional outcome scores of implanted subjects at out to 10 years follow-up.
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 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 implanted with DYNASTY® BIOFOAM® Acetabular Shells
- •Subjects implanted with a metal-on-metal articulation
- •Subjects implanted with non-MicroPort Orthopedics components (femoral heads, acetabular shells, acetabular liners) in the enrolled THA
- •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 or have 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 component survivorship of all components out to 10 years follow-up.
次要结局
- Patient functional outcomes(Screening (First Available), 2-5 years, 5-7 years, and 10 years)