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临床试验/NCT00293774
NCT00293774已完成不适用

A Provincial Initiative to Examine the Efficacy, Cost-effectiveness and Long-term Safety of Alternative Hip Bearing Surfaces Versus Conventional Therapy for Degenerative Joint Disease of the Hip

Alberta Bone and Joint Health Institute1 个研究点 分布在 1 个国家目标入组 1,632 人开始时间: 2004年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,632
试验地点
1

研究概览

简要总结

A study to determine the effectiveness and safety of the use of metal-on-metal hip resurfacing (for example the birmingham hip) when compared to conventional total hip replacement.

详细描述

This study is designed to provide orthopedic surgeons and decision makers with evidence-based health measures for patients that are treated by orthopedic surgeons for degenerative joint disease of the hip in Alberta. This study is provincial initiative to determine whether new alternative hip bearing surfaces improve patient outcomes and/or decrease health resource utilization in patients with degenerative joint disease of the hip in Alberta. The primary objective is to compare time to revision for patients receiving alternative hip bearing surfaces to patients receiving conventional total hip replacements. Secondary objectives are to evaluate long-term safety; to evaluate costs; to determine if alternative hip bearing surfaces improve patient function; to develop evidence base guidelines for the implementation of alternative hip bearing surfaces in Alberta; do develop a modal to assess other technologies and health advances; to develop an Alberta HIP registry

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • documentation of DJD of hip
  • patient at least 18 years
  • patient able to provide written consent
  • Male under 65 years, female under 56 years
  • Orthopedic surgeon has received appropriate training to implant an alternative device

排除标准

  • renal failure (MOM only)
  • child bearing potential (MOM only)
  • inappropriate femoral anatomy, including evidence of osteoporosis
  • inflammatory arthritis (MOM)
  • Unwilling to consent

研究者

发起方
Alberta Bone and Joint Health Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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