NCT04301622进行中（未招募）不适用
Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur With Cruciate Sacrificing Inserts
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Individual component survivorship
研究概览
简要总结
MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® BIOFOAM® Tibia and EVOLUTION® Cruciate Sacrificing/Cruciate Retaining (CS/CR) Porous Femur components, including EVOLUTION® CS tibial inserts. This type of study is required by regulatory authorities for all devices that have been approved in Europe to evaluate the medium and long-term clinical evidence.
详细描述
The objectives of this study are:
- To estimate the individual component survivorship of EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur components, including EVOLUTION® CS tibial inserts
- To find out the cumulative incidence of component revision of each component in this combination.
- To find out the functional outcome scores at early, midterm, and long term 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 previously undergone or currently has determined to undergo a primary TKA with the specified combination of components: EVOLUTION® CS/CR Porous Femur, EVOLUTION® CS Tibial Insert, and EVOLUTION® BIOFOAM® Tibia and modular keel
- •Has previously undergone or currently has determined to undergo a primary TKA for any of the following:
- •non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- •inflammatory degenerative joint disease including 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 (+6 months) of their primary TKA implantation
排除标准
- •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 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 issues
- •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
Individual component survivorship
时间窗: 10 years post-operative
Individual component survivorship for tibial base, femoral, and tibial CS insert at specified intervals out to 10 years follow-up.
次要结局
- Patient Reported Outcomes- Forgotten Joint Score(10 years post-operative)
- Patient Reported Outcomes- Knee Injury and Osteoarthritis Outcome Scores(10 years post-operative)
- Incidence of component revision(10 years post-operative)
- Radiolucencies(10 years post-operative)
- Adverse Events and Adverse Device Effects(10 years post-operative)
- Patient Reported Outcomes- EuroQol-5D-5L Scores(10 years post-operative)
- Patient Reported Outcomes- Satisfaction Survey(10 years post-operative)
研究者
研究点 (1)
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