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临床试验/NCT00253838
NCT00253838已完成不适用

A Randomized Controlled Trial Comparing a Titanium to a Cobalt Chrome Femoral Stem in Revision Hip Arthroplasty: A Pilot Study

Ottawa Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2001年10月最近更新:
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
39
试验地点
2
主要终点
Safety of surgical implant

研究概览

简要总结

This study compares two different hip stem components. Both hip stems used in this study allow the femur bone to attach and grow into them for stability. The main difference between the two stems is that one of the stems, the Solution® Stem, is made from Cobalt Chrome, a type of metal, and does not have a hydroxylapatite (HA) coating, while the second stem included in the study, the Restoration hip stem, is made from titanium alloy, a different type of metal that has a roughened surface and allows for a hydroxylapatite (HA) coating to be applied to the entire length of the stem. The HA coating is a thin calcium phosphate layer on the stem to encourage the bone to grow into it. We are trying to see if there is any difference in the initial bony ingrowth between the two stems and to compare the results in patients over the first two years after the surgery and then again at the five-year period.

详细描述

Revision total hip arthroplasty is becoming increasingly common due to the large number of primary total hip arthroplasties being performed annually. Failure of these arthroplasties has led to an increasing number of patients requiring revision arthroplasty. Various methods have been used to reconstruct the hip during a revision procedure. These have generally consisted of a cemented or uncemented femoral stem. It is now generally accepted that uncemented femoral stems have improved results over cemented stems, especially in those cases with compromised bone stock. There are two main alloys used for the femoral revision component, that is cobalt chrome and titanium. There may be certain advantages to the use of titanium, in particular, a reduction in future bone loss caused by stress shielding. Stress shielding is commonly seen with cobalt chrome implants. In order to assess this and the overall survival of these two different implants a randomized clinical trial is proposed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Candidates for revision hip arthropathy

排除标准

  • Under 21 years of age

研究组 & 干预措施

Restoration HA Stem

Active Comparator

The Restoration hip stem, is made from titanium alloy, a different type of metal that has a roughened surfacing and allows for a hydroxylapatite (HA) coating

干预措施: Restoration HA stem (Procedure)

Solution stem

Sham Comparator

The Solution stem is made from Cobalt Chrome, a type of metal, and does not have a hydroxylapatite (HA) coating.

干预措施: Solution stem (Procedure)

结局指标

主要结局

Safety of surgical implant

时间窗: 24 months

Safety of surgical implant will be assessed by reviewing revision rates and complication rates post surgery

次要结局

  • Effectiveness of surgical implant(24 months)
  • Patient outcome measures(pre-op, 6, 12, 24, 60 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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