Radiographic Migration Analysis of the ATTUNE Cementless CR Fixed-Bearing Total Knee Replacement: A Multi-Center, Non-Controlled, Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- 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 Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System.
详细描述
All patients will undergo post-operative radiostereometric analysis (RSA) and computed tomography (CT) to quantify and characterize the in vivo migration pattern of the Attune AFFIXIUM Cementless Tibial Baseplate and the Attune POROCOAT Cementless Femoral Component up to 24 months. 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 total knee arthroplasty
- •Patients aged 21 years or older
- •Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
- •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 of ipsilateral extremity
- •Medical condition precluding major surgery
- •Inflammatory arthropathy
- •Posterior cruciate ligament (PCL) deficiency
- •Major coronal plane deformity
- •Conditions that are cautioned against or contraindicated, as listed in the product monograph and/or instruction for use
- •Bone defects requiring augments, cones and/or stemmed implants
结局指标
主要结局
Tibial baseplate stability
时间窗: 6-12 months, 1-2 years post-operative
Maximum total point motion (MTPM) migration between 6-12 months and 1-2 year post-operative (mm)
次要结局
- Linear depth (wear) on the tibial insert(Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years)
- Femoral component migration(Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years)
- Oxford Knee Score(Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years)
- Satisfaction VAS(Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years)
- Patient complications(Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years)
- Equivalency between CT-RSA-measured migration and the gold-standard of RSA-measured migration(Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years)
- European Quality of Life (EQ-5D-5L)(Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years)
- Tibial baseplate migration(Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years)
- Forgotten Joint Score (FJS)(Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years)