A Prospective, Multicenter, RSA Study of the Porous Tibia Baseplate W/Jrny Lock
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Change between 6 months and 1-year post-operative - tibial baseplate stability
研究概览
简要总结
This is a multi-centre single cohort trial of patients undergoing cruciate-retaining total knee arthroplasty with the Advance Porous fixed bearing tibial baseplate and compatible femoral, patellar, and bearing components.
详细描述
All patients will undergo post-operative model-based RSA to identify migration of the tibial baseplate with respect to the bone as well as migration of the patellar and femoral components with respect to the bone during the first 2 post-operative years. Patient health and functional outcomes will be recorded at pre- and post-operative intervals for all patients. Peri-operative adverse events and other clinical complications will be captured as encountered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptomatic osteoarthritis of the knee indicating primary unilateral total knee arthroplasty
- •Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
- •Aged 21 years or older
- •Patients willing and able to comply with follow-up requirements and self-evaluations
- •Ability to give informed consent
排除标准
- •Active or prior infection
- •Medical condition precluding major surgery
- •Known medical condition limiting patient life expectancy to < 2 years
- •Expected to receive contralateral TKA within 1 year
- •Inflammatory arthropathy
- •Prior patellectomy
- •PCL deficiency
- •Major (>25 degree) coronal plane deformity
- •Bilateral coronal plane deformity requiring simultaneous bilateral TKA
- •Bone defects requiring augments, cones and/or stemmed implants
- •Body Mass Index greater than 40
结局指标
主要结局
Change between 6 months and 1-year post-operative - tibial baseplate stability
时间窗: 6 Months and 1 Year
Maximum total point motion (MTPM) migration of the POROUS TIBIA BASEPLATE W/ JRNY LOCK between 6 months and 1 year post-operative (mm)
次要结局
- Total MTPM migration of the baseplate at 1 year(1 Year)
- Change between 1- and 2-years post-operative - tibial baseplate stability(1 Year and 2 Years)
- Establish the post-operative migration pattern of the patellar and femoral components(6 Weeks and 6 Months)
- Forgotten Joint Score (FJS)(Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years)
- University of California at Los Angeles (UCLA) Activity Level scale(Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years)
- Satisfaction VAS(Preoperative, 6 Months, 1 Year and 2 Years)
- European Quality of Life (EQ-5D-5L)(Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years)
- Patient-reported Outcome: Oxford Knee Score(Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years)
- Knee Injury and Osteoarthritis Outcomes Score (KOOS JR.)(Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years)
- What is the magnitude of baseplate displacement that results from patient weight-bearing (single leg stance) versus non-weight-bearing at 1-year post-operation?(1 Year)
- Pain VAS(Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years)
- Patient complications(6 Weeks, 6 Months, 1 Year and 2 Years)