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临床试验/NCT02331264
NCT02331264已完成不适用

Cardiac Assessment of Patients With Hip Implants

Royal National Orthopaedic Hospital NHS Trust2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年11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
90
试验地点
2
主要终点
Cardiac Ejection Fraction

研究概览

简要总结

PRIMARY OBJECTIVE To establish the effect of metal ion release from metal hip implants on cardiac function

STUDY OUTCOME MEASURES

To assess the effect of metal ions from hip implants on cardiac function as measured by Cardiac Magnetic Resonance Imaging (CMR) and Echocardiogram. This involves the surrogate detection of cobalt ion deposition within cardiac tissues and assessment of ejection fraction and tissue characterization (with and without contrast).

STUDY IMPACT

With 60,000 patients having a metal on metal (MOM) hip implant in the United Kingdom (UK), and over a million worldwide, there is need to clarify this important question, which is the source of significant concern amongst patients and surgeons alike. Also, this problem is not unique to MOM hips since all hip implants contain metal and as seen in various case reports high blood cobalt levels have arisen after catastrophic failure (e.g. fracture of a ceramic bearing surface) leading to abnormal wear of the implant and release of metal ions into the body. In the UK, over 80,000 hip implants are inserted annually.

详细描述

BACKGROUND

Metal-on-metal (MOM) hip implants have a risk of releasing metal ions upon wear of the component material. Some of the metal ions (e.g. cobalt and chromium) from the metal implant or from the metal particles will enter the bloodstream.

The Food and Drug Administration (FDA, USA) recently highlighted systemic toxicity from metal on metal hip implants as a cause for concern and recommended that patients with systemic symptoms are assessed with a particular focus on cardiovascular, neurological, endocrinological (especially thyroid), and renal systems.

A number of cases of suspected toxicity to circulating cobalt and chromium from MOM hip implants, including cardiac toxicity, have been reported recently. The most profound case involves a patient who died from cardiac failure secondary to cardiomyopathy and cobalt deposition within the cardiac tissues. A recent cross sectional health screen and isolated case reports, suggest that raised metal ion levels have the potential to cause cardiomyopathy and cardiac failure. Such cases have raised public anxiety in the process.

Blood metal ions released from metal hip implants are increasingly recognized as a potential cause of local and distant abnormal tissue responses, since cobalt and chromium is released into the peri-prosthetic tissues and transported systemically throughout the body. Component design and positioning are associated with increased wear and as a result raised metal ion levels. However, a definitive causal link to systemic symptoms still remains to be established.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Age over 18 years of age
  • Either male or female
  • Metal on Metal hip implant (ceramic on ceramic hip implant for patients within control group)
  • Implanted greater than 12 months (i.e. beyond the bedding in period of the implant)
  • Suitable for MRI scanning (no contraindications for Magnetic scanning - for instance metal implants in eyes/brain/heart, and claustrophobia)
  • Consenting to the proposed research activity

排除标准

  • Age below 18 years
  • Metal hip implant not considered as MOM or Ceramic on Ceramic (COC) if part of the control group
  • Not suitable to undergo MRI scanning (contra-indications or claustrophobia)
  • Revised hip implant
  • Atrial Fibrillation
  • Poor renal function (eGFR<30)
  • Consent not given
  • Vulnerable adults

结局指标

主要结局

Cardiac Ejection Fraction

时间窗: 1 hour

Use of Echocardiogram and Cardiac MRI (Gold Standard) for assessment of ejection fraction of the heart

次要结局

  • Detection of Cobalt Metal Ion deposition within cardiac tissues(30 mins)

研究者

发起方
Royal National Orthopaedic Hospital NHS Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Alister Hart

Professor Alister Hart, Professor of Orthopaedic Surgery, Director of Research and Development

Royal National Orthopaedic Hospital NHS Trust

研究点 (2)

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