NCT04147559Enrolling By Invitation不适用
Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Component Survivorship
研究概览
简要总结
Sponsor is conducting this post market clinical study to evaluate the safety and effectiveness of its PROFEMUR® Preserve Classic Femoral Stem. This type of study is required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long-term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 (European Medical Device Vigilance System) rev2 and ISO (International Organization of Standardization) 14155:2011 guidelines.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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 previously undergone or currently has determined to undergo primary THA with the specified combination of components: PROFEMUR® Preserve Classic Stem combined with other Wright Medical Technologies (WMT) or MPO THA components including acetabular shells, acetabular liners and femoral heads.
- •Has previously undergone or currently has been determined to undergo a primary THA for any of the following:
- •non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- •inflammatory degenerative joint disease such as rheumatoid arthritis;
- •correction of functional deformity
- •Willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit
- •Previously implanted subjects must be enrolled within 3 years of their primary THA implantation.
排除标准
- •Implanted with non-MPO or non-WMT components (femoral heads, acetabular shells, acetabular liners)
- •Skeletally immature (less than 21 years of age) at time of implantation
- •Has or had an overt infection at the time of implantation
- •Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
- •Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
- •Has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
- •Has or had neuropathic joints
- •Has or had hepatitis or HIV infection
- •Has or had a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
- •Has had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
- •Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
- •Unwilling or unable to sign the Informed Consent document
- •Has documented substance abuse issue
- •Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- •Currently incarcerated or has impending incarceration
- •Has a medical condition, as judged by the investigator, that would interfere with the subject's ability to comply with the requirements of the protocol -
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 the PROFEMUR® Preserve Classic Femoral Stem out to 10 years follow-up.
次要结局
- To evaluate the presence of zones of radiolucencies surrounding the implanted femoral stem(10 years post-operative)
- Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by HOOS.(10 years post-operative)
- To characterize adverse events and adverse device effects(10 years post-operative)
- To determine the cumulative revision rate at specified intervals out to 10 years follow-up(10 years post-operative)
- To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Forgotten Joint Score (FJS).(10 years post-operative)
- To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Satisfaction Survey.(10 years post-operative)
- Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by EQ-5D-5L(10 years post-operative)
研究者
研究点 (2)
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