Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score- Joint Replacement (KOOS JR)
研究概览
简要总结
MicroPort Orthopedics Inc. (MPO) plans to market the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert globally, including in the European Union (EU). MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur. These components are used along with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert components that is marketed in the European Union (EU). This type of data collection is required by regulatory authorities for all TKA devices that do not have medium to long-term clinical evidence available.
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
- •Subjects > 18 years of age at the time of surgery
- •Subjects who were implanted with the Evolution® NitrX (SKU # listed below) in MicroPort Orthopedics' intended patient population listed within the Instructions for Use (IFU).
- •Willing and able to participate in clinical study
排除标准
- •Subjects without follow-up history
- •Subjects not meeting the inclusion criteria
- •Contraindications as listed in the IFU
- •Currently enrolled in another study that could affect the endpoints of this protocol.
研究组 & 干预措施
Newly or previously implanted patients
Single center, non-interventional prospective follow-up of newly or previously implanted subjects. Previously implanted subjects must be enrolled within 14 months of the study index surgery. Single study group with either newly or previously implanted patients with all EVOLUTION® NitrX™ components: Non-Porous Keeled Tibia, CS/CR Non-Porous Femur component, and EVOLUTION® MP CS tibial insert
干预措施: EVOLUTION® NitrX™ (Device)
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score- Joint Replacement (KOOS JR)
时间窗: 10 years
KOOS is a validated patient-reported outcome measure designed to assess short- and long- term symptoms and functions in individuals with knee injuries and osteoarthritis. It is a 42-item questionnaire. KOOS JR is its short form, developed using Rasch analysis to provide a more efficient tool for clinical and research use. It has 7 items which measure pain, stiffness and function in daily life. Each item is scored from 0 (none) to 4 (extreme). The raw score (0-28) is converted to an interval score ranging from 0 to 100, where 100 indicates the best health and 0 means the worst health.
次要结局
未报告次要终点