A Prospective, Multicenter, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of the JOURNEY™ II XR Total Knee System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 176
- 试验地点
- 14
- 主要终点
- Implant survival rate
研究概览
简要总结
This study was designed to demonstrate the safety and performance of the JOURNEY II XR total knee system by evaluating implant survival rates at 10 years using Kaplan-Meier analysis. All participants will be implanted with the JOURNEY II XR total knee system.
详细描述
Total knee arthroplasty (TKA) is considered the most beneficial and cost-effective treatment for end-stage knee arthritis and is the most frequently performed joint replacement surgery. TKA is also indicated for earlier osteoarthritis (OA) interventions, such as osteotomy or unicompartmental replacement, when additional treatment is warranted. One device option available once the decision is made to perform TKA is the JOURNEY II XR Total Knee System. The JOURNEY II XR Total Knee System is designed to be a more "natural feeling" total knee replacement. The goal of the JOURNEY II XR is to enable a higher level of function after total knee replacement by relieving pain and restoring the ability to participate in active lifestyles. The main aim of this study is to generate long-term safety and performance data for the JOURNEY™ II XR Total Knee System. Effectiveness information such as short- and long-term function, subject satisfaction, and quality of life will also be measured.
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
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •require TKA due to rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis, failed osteotomies, or failed unicompartmental replacement
- •have all cruciate and collateral ligaments intact in the index joint
- •adult patients that in the judgement of the Investigator are skeletally mature
- •be willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires
- •consent to participate in the study by signing the IRB/EC approved informed consent form
排除标准
- •have any of the following conditions in the index joint:
- •Intra-articular corticosteroid therapy (or any other intra-articular therapy) in the study knee within 3 months of study enrollment
- •Significant varus or valgus deformities (>15º)
- •Incomplete or insufficient tissue surrounding the knee
- •Collateral ligament insufficiency
- •Inadequate bone stock to support the device (e.g., severe osteopenia/osteoporosis) or will require use of femoral and tibial stems
- •History of prior TKA
- •have any of the following conditions in the contralateral joint:
- •a previous TKA as a revision for a failed total or unicondylar knee arthroplasty
- •a primary TKA or unicondylar knee arthroplasty that is not fully healed and well-functioning as determined by the Investigator
- •have any of the following conditions of the hip:
- •a previous contralateral or ipsilateral revision hip arthroplasty
- •ipsilateral hip arthritis resulting in flexion contracture
- •previously received an ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty that is not fully healed and well-functioning as determined by the Investigator
- •have a diagnosis of an immunosuppressive disorder
- •have an active infection, treated or untreated, systemic or at the site of the planned surgery
- •have conditions that may interfere with the TKA survival or outcome, including but not limited to: Paget's disease, Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease
- •have a BMI > 40
- •be facing current or impending incarceration
- •have a known allergy to study device or one or more of its components
- •be pregnant or have plans to become pregnant during the course of the study
- •have, in the opinion of the Investigator, an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse
- •be enrolled in another drug, biologic, or device study within 30 days of screening
- •be known to be at risk for lost to follow-up or failure to return for scheduled visits
- •during the surgery, have a cruciate ligament tibial bone island that is secured with any fixative device (e.g. screw, plate, etc.).
结局指标
主要结局
Implant survival rate
时间窗: 10 years
Did knee survive with no revision through 10 years
次要结局
- Quality of Life - FJS(10 years)
- Quality of Life - KOOS(10 years)
- Physiotherapy (PT) utilization - Period of visits(6 Months Post-operatively)
- Quality of Life - ABC scale(10 years)
- Radiographic outcomes(10 years)
- Adverse Events (AEs)(10 years)
- Knee function(10 years)
- Quality of Life - EQ-5D - 3L(10 years)
- Quality of Life - SAPSS(10 years)
- Physiotherapy (PT) utilization - No. of visits(6 Months Post-operatively)