NCT03576573Enrolling By Invitation不适用
Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 143
- 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) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in Europe. 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
- •To be included in the study, subjects must meet all of the following criteria:
- •Has previously undergone primary Total Hip Arthroscopy 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;
- •Correction of functional deformity
- •Subject was implanted with the specified combination of components, namely, any MicroPort Orthopedics or Wright Medical Technology femoral stem and PROCOTYL C Acetabular Components
- •Subject is willing and able to complete required study visits or assessments
- •Previously implanted bilateral subjects can have both THAs (Total Hip Arthroscopy) enrolled in the study provided:
- •the specified combination of components were implanted in both,
- •all other aspects of the Inclusion/Exclusion Criteria are satisfied,
- •enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and
- •the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrolment of a previously unimplanted hip is not permitted in this study.
排除标准
- •Subjects will be excluded if they meet any of the following criteria:
- •Subject was skeletally immature (less than 21 years of age) at time of implantation
- •Subject has a non-MicroPort or non-Wright Medical Technology component implanted (femoral heads, acetabular shells, acetabular liners) in the enrolled Total Hip Arthroscopy
- •Subject is currently enrolled in another clinical investigation which could affect the endpoints of this protocol
- •Subject is unwilling or unable to sign the Informed Consent document
- •Subject has documented substance abuse issues
- •Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- •Subject is currently incarcerated or has impending incarceration
结局指标
主要结局
Component Survivorship
时间窗: 10 years post-operative
The primary endpoint is to evaluate component survivorship of the PROCOTYL® C Acetabular Components out to 10 years follow-up. Percentage of hips survived with no revision or replacement at 10-year.
次要结局
- To determine the cumulative incidence of component revision at specified intervals out to 10 years follow-up;(2-5 years, 5-7 years, and 10 years)
- To characterize functional scores, as assessed by Oxford Hip.(2-5 years, 5-7 years, and 10 years)
- To characterize functional scores, as assessed by EQ-5D-3L scores.(2-5 years, 5-7 years, and 10 years)
研究者
研究点 (1)
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