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临床试验/NCT02525809
NCT02525809已完成不适用

Incidence of Dual Mobility Polyethylene Wear in Total Hip Prosthesis. Randomised Study Versus Fixed Insert by Radiostereometric Analysis.

University Hospital, Caen0 个研究点目标入组 82 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
82
主要终点
Measuring the penetration of the femoral head in the polyethylene inserts by radiostereometric analysis (RSA)

研究概览

简要总结

The total hip replacement, with over 120,000 cases per year in France, provides short term, excellent functional results and a significant improvement in quality of life, in almost all cases. However, observation showed that the dislocation is not a rare complication (2-4%) and the lifetime of the implants is limited due to aseptic loosening.

The evaluation process used in this study will be the extent of penetration of the metal femoral head in the cup and micro mobility metal back by radiostereometric analysis (RSA) whose precision provides early results (2 3 years), long before wear and migration are measurable by conventional radiological means. The main objective will be to compare, 2 years after the intervention, the penetration of the metal femoral head in 3 types of inserts: two dual mobility inserts, one at tripod attachment (Novae E®), the other press fit pure (Sunfit®), and a fixed insert (Quartz®).

This is a randomized controlled trial. 105 patients will be enrolled (35 in each group). Patients will be included in each of the two participating centers (Amiens, Caen). The analysis will be made in RSA D7 + 2, 6 months 1, 12 months 1 24 months 1. An assessment will be made to 3 years if the analysis requires it to 2 years.

Analysis of pictures will be centralized in Caen and performed with specific software after transferring images via a secure network.

研究设计

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

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients older men or women 60-75 years
  • with a primary or secondary osteoarthritis or osteonecrosis
  • having a functional disorder requiring the installation of a total hip prosthesis of primary

排除标准

  • patients aged 76 years or more
  • protected adults
  • resumption of PTH
  • cephalic prosthesis recovery or intermediate
  • resumption of cupules
  • primary or secondary malignant tumor of the hip

结局指标

主要结局

Measuring the penetration of the femoral head in the polyethylene inserts by radiostereometric analysis (RSA)

时间窗: change over baseline and 3 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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