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临床试验/NCT01437124
NCT01437124已完成不适用

Measurement of Metal Ion Levels and Chromosome Abnormalities in Ceramic on Metal Total Hip Arthroplasty in Vivo

Hussain Kazi1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2011年10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
83
试验地点
1
主要终点
Cobalt Chromium Levels

研究概览

简要总结

The investigators aim to measure the blood levels of certain metals in a group of patients all of whom have had a ceramic on metal total hip replacement. This new bearing surface (joint) is relatively new and the investigators are currently following up the largest cohort in the world. Clinical results are currently excellent at 2 years in all patients, however the investigators are mindful of the lessons learned from the high failure rate of several designs of metal on metal hip replacements as well as several in vitro reports and one in vivo case report of elevated metal levels in this particular implant. The investigators feel it is important to measure the metal ion levels in our group to ascertain and compare these with reference standards. Once performed the investigators can relate ion levels to function and x ray changes and provide useful longterm data to the patients and the wider medical community as to whether this bearing surface is safe in the long term or whether it's use should be abandoned. This is useful as there are numerous groups implanting this device in the UK and in addition it has just been awarded FDA approval in the USA - its use is likely to flourish.

详细描述

PURPOSE & DESIGN:

The investigators are currently following up a cohort of patients all of whom have had a metal on ceramic total hip arthroplasty.

This new bearing couple has been approved for use in the UK for some time and has recently achieved USA FDA approval.

The attraction of this bearing couple is a low rate of wear with reduced complications associated with ceramic on ceramic bearing such as bearing fracture.

Of recent media attention has been the unacceptably high failure of the DePuy ASR metal on metal hip resurfacing. This metal on metal bearing couple has been associated with increased ion levels and chromosome abnormalities in vivo.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 18 years of age
  • Complete history and physical examination
  • Previously performed ceramic on metal total hip replacement
  • An understanding of the purpose of the study and signed consent form

排除标准

  • Hip arthroplasty other than ceramic on metal bearing
  • Mentally infirm / incapacitated
  • Incomplete history or physical examination
  • Unwillingness to participate in the study

结局指标

主要结局

Cobalt Chromium Levels

时间窗: 2 years post THR

Serum cobalt chromium levels post THR

次要结局

  • Chromosomal Abnormality(2 years post THR)

研究者

发起方
Hussain Kazi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hussain Kazi

Specialist Registrar, Trauma and Orthopaedics

Wirral University Teaching Hospital NHS Trust

研究点 (1)

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