A Prospective, Randomized Study Comparing Cemented and Cementless Total Knee Replacement: Results of a New Modular Trabecular Metal Tibial Component Using the NexGen System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 主要终点
- Complications
研究概览
简要总结
The purpose of this study is to compare the the Nexgen knee replacement system using cementless fixation with the same system using cemented fixation. At minimum 2-year follow-up, the hypothesis is that NexGen total knee arthroplasties using cementless and cemented fixation will demonstrate no differences in clinical outcome based on Oxford and Knee Society scores, patient-assessed visual analog pain, clinical complications, radiographic fixation and implant survivorship.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of osteoarthritis of the knee
- •Patients undergoing primary total knee replacement
排除标准
- •Age over 75 years old
- •Prior unicondylar knee arthroplasty
- •Grossly porotic bone or bone defects requiring bone grafting
- •Bone cuts not sufficiently accurate for cementless fixation
结局指标
主要结局
Complications
时间窗: 15 year
The number and type of adverse events will be monitored to assess safety.
Radiographic analysis
时间窗: 4 month
Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
次要结局
- Oxford Knee Score(15 year)
- Knee Society Score(15 year)
- Visual analog pain score(4 month)
研究者
Kevin B. Fricka, MD
Principal Investigator
Anderson Orthopaedic Research Institute