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临床试验/NCT01818401
NCT01818401已完成不适用

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

Nantes University Hospital2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2013年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
95
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

Over 70.000 total knee arthroplasty (TKA) are performed in France every year, with a 10% yearly increase since the early 1990s. The clinical experience shows a strong rate of success on pain relief and on function. Longevity of the implants has been shown to be determined by the biomechanical design of the prosthesis, and by the implantation technique, especially the correct positioning of the bone cuts during the surgery. To improve the precision of these cuts, the patient matched cutting blocks developed by Medacta allow to adapt the bone cuts to the patient's anatomy, improving the reliability of this procedure. A reduction of the surgery time lengh and bleeding would be other benefits expected with this type of ancillary. The objective of this trial is to study the reliability of patient matched cutting blocks for total knee arthroplasty, by both clinical and radiological assessment, the effect on morbidity reduction during and after the procedure and also the benefit it could bring 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

研究组 & 干预措施

Control group

Other

The control group will be constituted of patients with the prosthesis GMK ® without the ancillary MyKnee ® LBS.

干预措施: the prosthesis GMK ® without the ancillary MyKnee ® LBS (Device)

Matched patient

Other

The treated group will consist of patients which the GMK ® prosthesis with ancillary ® MyKnee LBS.

干预措施: Matched patient cutting blocks MyKnee ® LBS (Device)

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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