In-vivo Study Investigating the Difference in Functional Outcome Between Two Types of Knee Prostheses: the Sigma FB (Depuy, J&J, UK; Standard Implant) and the Sigma RP-F (Depuy, J&J, UK; High-flexion Implant)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Thigh-calf contact force
研究概览
简要总结
The purpose of this study is to investigate whether subjects receiving a high-flexion knee prosthesis show a better knee function than patients receiving a standard knee prosthesis. Thigh-calf contact force measurements are used to quantify knee function. The investigators' hypothesis is that high-flexion knees show a better knee function.
详细描述
Study title:
Functional evaluation of a standard and a high-flexion knee prosthesis using thigh-calf contact force measurements.
Objective:
The objective of this study is to investigate whether subjects receiving a high flexion knee prosthesis (Sigma RP-F, J&J, UK) show a better knee function than patients receiving a standard knee prosthesis (Sigma FB, J&J, UK).
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving a total knee replacement due to disabling gonarthrosis (cartilage damage):
- •Primary due to osteo-arthritis
- •Secondary due to rheumatoid arthritis or trauma
排除标准
- •Patients suffering from juvenile rheuma
- •Patients suffering from hemophilia
- •Patients that are incapable to give informed consent
- •Patients who receive a total knee replacement due to an oncological resection
- •Patients who have received a total knee replacement on the contralateral leg
- •Patients who have disabling gonarthrosis on both legs
- •Patients having a BMI < 25 kg/m^2
- •Patients who have to receive a different prosthesis than used in this study for biomechanical reasons (e.g. revision prosthesis)
结局指标
主要结局
Thigh-calf contact force
时间窗: pre-op and 1-year post-op
次要结局
- BMI, weight and length(pre-op and 1-year post-op)
- Passive/active maximal knee flexion angle(pre-op and 1-year post-op)
- Thigh and calf circumference(pre-op and 1-year post-op)
- IKS, WOMAC and VAS (pain/satisfaction) score(pre-op and 1-year post-op)