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临床试验/NCT01814384
NCT01814384Unknown不适用

Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®. Multicentric, Prospective, Controlled, Opened, Randomised Study About Medical Device.

Nantes University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
compare the functionality of the knee after installation of a total knee replacement between the 2 groups

研究概览

简要总结

Total knee arthroplasty represents over 70 000 surgical procedures per year in France, increasing about 10% each year since the early 1990s. Clinical experience shows a strong rate of success on pain relieve and improvement of knee articular function for these patients.

Longevity of the implants had been proved to depend on the biomechanical design and implantation techniques, particularly the bone cuts during the surgery. To improve the precision of these cuts, the patient matched cutting blocks developed by Medacta company allows to adapt bone cuts to the patient anatomy improving the reliability of these procedure. A reduction of surgical time and bleeding would be another benefit expected with this type of ancillary. The objective of this study is to demonstrate the advantage of patient matched cutting blocks for total knee arthroplasty on realiability for both clinical and radiological criteria, morbidity reduction during and after the procedure and also a benefit on an economic point of view.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

入选标准

  • all patients requiring a total knee arthroplasty line: primary or secondary osteoarthritis advanced beyond medical treatment.

排除标准

  • distorded axes or laxity requiring the establishment of constrained prosthesis

结局指标

主要结局

compare the functionality of the knee after installation of a total knee replacement between the 2 groups

时间窗: 2 years after

The evaluation will use a specific score for total knee arthroplasty: Part of the Knee Society function score (KSS) measured at 1 year after surgery.

次要结局

  • to assess knee function by autoquestionnaire KOOS, the KSS knee score, operative time, procedure bleeding, reliability of the ancillary(2 years after)
  • medico-economic evaluation type "Cost minimization"(2 years after)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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