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临床试验/NCT01659229
NCT01659229Unknown不适用

Fluoroscopic Analysis Comparing the Dynamic Flexion of 2 Different Knee Arthroplasty Implants

Singapore General Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
12
试验地点
1
主要终点
Flexion-extension range of movement of operated knee

研究概览

简要总结

The investigators are comparing the range of movements the knees of patients who had total knee replacement surgery for knee osteoarthritis. In the study arm, the implant used was a Sigma Cruciate Retaining (CR) Press Fit Condylar (PFC) 150, which is a high flexion knee system designed to combine function with wear resistance. It can accommodate up to 150 degrees of knee flexion. In the cohort arm, the implant used was the standard Sigma CR which can accommodate up to 120 degrees of flexion.

详细描述

Both sets of patients will undergo routine post-operative follow up in clinic. The study involves patients who had their surgery more than 2 years ago. We assess their range of movement using fluoroscopy. They are asked to perform lunges, squats and climbing up and down 3 steps. The fluoroscopic images are then analysed to assess their individual range of movements.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients who underwent total knee replacement surgery who received either the PFC CR 150 knee implants or the PFC CR standard knee implant
  • Surgery more than 2 years
  • Able to walk, climb stairs

排除标准

  • Knee stiffness with less than 100 degrees of knee range of movement
  • Patients who required revision surgery
  • Patients who received an all polyethylene tibial insert
  • Patients who received rotating platform tibial tray

结局指标

主要结局

Flexion-extension range of movement of operated knee

时间窗: 2 years after their total knee replacement surgery

Fluoroscopic studies are done as patient perform lunges, squats and climb up and down stairs.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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