NCT00294528Unknown4 期
Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex and AGC
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- ROM
研究概览
简要总结
A randomized blinded study is conducted comparing 2 different knee prostheses. Range of motion (ROM), pain, feel of prosthesis, satisfaction and ability to do daily activities are registered at intervals up to one year postop, where patients are informed on which prosthesis they received.
We want to:
- determine whether an increased ROM is achieved with a high-flex knee compared to a standard knee
- and if so, does it matter
详细描述
100 patients operated on with unilateral TKR are included and randomized to either prostheses.
Patients operated on with bilateral simultaneous TKR receive one of each prostheses but are blinded to which prosthesis is on which side. They have gait analyses performed preop and at intervals up to one year.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age below 75 years and active
- •preop ROM at least 120 degress flexion
- •BMI below 30
- •intact ligaments
排除标准
- •below 18 years
- •unable to understand language or purpose
结局指标
主要结局
ROM
Pain
Satisfaction
Feel of prosthesis
Gait analysis
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Randomised Controlled Trial PFC Versus CKS Total Knee ProsthesesOsteoarthritis, KneeNCT00228137Radboud University Medical Center90
已完成
不适用
Prospective Double-blinded Randomised Comparison of Profix Mobile to Fixed Bearing Knee ReplacementsOsteoarthritisNCT02157220The University of New South Wales77
已完成
4 期
Sigma CR150 Versus Sigma CR Knee RCTOsteoarthritisNCT01418378DePuy International191
撤回
不适用
Comparison Between Two Total Knee Prosthesis Medacta GMK Sphere and Medacta GMK PSKnee OsteoarthritisNCT03896451Kantonsspital Winterthur KSW
招募中
不适用
Persona MC vs PS RCT With ROSATotal Knee ArthroplastyNCT05391828NYU Langone Health200