Follow-Up of Subjects With a Journey™ UNI Unicompartmental Knee System Implant
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 147
- 试验地点
- 4
- 主要终点
- Implant survival rate
研究概览
简要总结
This is a retrospective/prospective, open-label single cohort, multicenter study to collect relevant clinical data from 147 subjects with unicompartmental degeneration of the knee in whom the Journey UNI UKS was previously implanted.
详细描述
The purpose of the current investigation is to assess the safety and effectiveness of the JOURNEY UNI Unicompartmental Knee System (UKS) in patients with non-inflammatory degenerative joint disease (NIDJD) of the knee who previously had the Journey UNI UKS implanted. This clinical study will prospectively evaluate the 36 and 60-month safety and performance of the JOURNEY UNI UKS in patients with NIDJD of the knee who required lateral or medial knee compartment replacement.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 12 and 48 months previously, subject had unicompartmental knee replacement implanted for unicompartmental, NIDJD including OA, traumatic arthritis, avascular necrosis, for correction of functional deformity, or to repair a fracture that was unmanageable using other techniques.
- •Subject received a Journey UKS implant (consisting of a femoral component, tibial baseplate, and a tibial insert).
- •Subject was considered skeletally mature at the time of surgery and was at least 18 years of age.
- •Subject is willing to have retrospective data collected and to participate in required prospective follow-up visit(s) at the investigational site and to complete study procedures and questionnaires.
- •Subject has consented to participate in the study by signing the Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent form (ICF).
排除标准
- •Subject has Body Mass Index (BMI) > 40 within 1 month of surgery.
- •Subjects who have received the Journey UNI UKS as part of a revision surgery.
- •Subject has a condition that may interfere with the unicompartmental knee arthroplasty (UKA) survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
- •Subject has a known allergy to study device or one or more of its components.
- •Subject, in the opinion of the Principal Investigator (PI), has an emotional or neurological condition that would preempt his/her ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
- •Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product in the past 30 days.
- •Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.
结局指标
主要结局
Implant survival rate
时间窗: 5 years
Did knee survive with no revision through 5 years
次要结局
- Quality of Life - KSS(5 Years)
- Radiographic Outcomes(5 Years)
- Quality of Life - Forgotten Joint Score(5 Years)
- Adverse Events (AEs)(5 Years)
- Quality of Life - EQ-5D - 3L(5 Years)
- Quality of Life - SAPSS(5 Years)