跳至主要内容
临床试验/NCT00894218
NCT00894218终止不适用

New Tool of Subjective and Objective Functional Evaluation and the Quality of Life After Arthroplastic Surgery of the Hip and the Knee Assisted or Not by Computer and Mini-invasive Arthroplasty

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2009年4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
终止
入组人数
1
试验地点
1
主要终点
To compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques

研究概览

简要总结

Hip or knee arthroplasties allow a relief of pain and a good functional habilitative at patients suffering from degenerative osteoarthritis of these articulations with medium and long-term good results. The main objective of this study is to compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques thanks to an innovative technology of ambulatory analysis of walking.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Weight < 100 kg
  • •score UCLA > 4
  • •prosthesis of first intention

排除标准

  • •score UCLA < 4
  • •osteotomy near to prosthesis
  • •prosthesis requiring an osseous transplant
  • •prosthesis already set up
  • •infections, contagious diseases (HIV, tuberculosis, hepatitis, venereal diseases) or metastasis
  • •neuromuscular diseases able to perturb walking or staying
  • •congenital or acquired disease, or previous surgery able to have consequences on results and prosthesis survey according to the surgeon

研究组 & 干预措施

Conventional arthroplasty

Active Comparator

Total hip or knee conventional arthroplasty

干预措施: Arthroplasty (Procedure)

Mini-invasive arthroplasty

Experimental

Total hip or knee mini-invasive arthroplasty

干预措施: Arthroplasty (Procedure)

Mini-invasive and computer-assisted arthroplasty

Experimental

Mini-invasive and computer-assisted total hip or knee arthroplasty

干预措施: Arthroplasty (Procedure)

结局指标

主要结局

To compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques

时间窗: 2 years after surgery

次要结局

  • Ambulatory analysis of the walking and coordination of lower limbs, direct and indirect costs(2 years after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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