Prospactive Randomized Monocentric Comparison Study Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PS
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in Knee injury and Osteoarthritis Outcome Score
研究概览
简要总结
The purpose of the study is to compare the clinical outcome after two total knee endoprosthesis designs Medacta GMK Sphere and Medacta GMK PS.
Primary outcome measures KOOS, Forgotten Knee Score and range of motion.
Single-center, randomized trial
详细描述
The clinical outcome measures were measured preoperativ and postoperativ (1 year, 5 year and 10 year).
Secondary outcome measures: number of reoperations and revisions, survival of the prosthesis
The patient population would consist patients with knee osteoarthritis eligible for total knee replacement
The aim of the study is to evaluate the effect of the knee prosthesis design on the patient outcome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •patient is eligible for a total knee replacement
- •patient is eligible for a Medacta GMK Sphere or Medacta GMK PS knee prosthesis
- •patient signed the informed consent
排除标准
- •patient is pregnant
结局指标
主要结局
Change in Knee injury and Osteoarthritis Outcome Score
时间窗: preoperative, 1 year, 5 year and 10 year after surgery
Knee injury and Osteoarthritis Outcome Score: 100 = maximum score, 0 = minimum score
Change in Forgotten Joint Score
时间窗: 1 year, 5 year and 10 year after surgery
Forgotten Joint Score: 100 = maximum score, 0 = minimum score
次要结局
- Change in revison(1 year, 5 year and 10 year after surgery)
- Change in range of motion(preoperative, 1 year, 5 year and 10 year after surgery)
研究者
Peter Koch
Principal Investigator: PD/MD
Kantonsspital Winterthur KSW