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临床试验/NCT01517737
NCT01517737Unknown不适用

Immune Cell Involvement in the Tissue Response to Metallosis in Patients With Failed Metal-on-metal Hip Replacements

University of East Anglia2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
105
试验地点
2

研究概览

简要总结

Metal-on-metal total hip replacement (MoM THR) has been targeted at younger patients with anticipated long-term survival since the bearing surfaces wear less than the traditional metal-on-plastic (MoP) replacements. However, the production of metal ions as a result of the wear is a concern because of the possible toxicity to cells. In Norwich England a number of different metal-on-metal implants have been trialed of which one, the Ultima TPS, has had very poor results. A total of 545 patients have had 652 MoM THRs with the Ultima TPS of whom more than 20% have now been revised. There is an ongoing MHRA program to screen for problems using MRI scans with a technique developed in Norwich. Investigations so far show massive corrosion in the implants with a catastrophic immune response causing death of cells. This may include death of bone leading to fracture. In a third of patients revised there has been pain but normal plain X-rays. In some patients without pain who have been screened there are abnormal changes on an MRI scan. We wish to investigate the immune cells in patients to find out why this has happened. The study will include patients coming for a new hip to act as a comparator, as well as those with a MoM THR and patients being revised with MoM THRs, and MoP THRs. We shall also investigate patients with other MoM THRs opportunistically.

详细描述

To characterize dendritic cell (DC) populations in MoM THR patients. Dendritic cells are cells that migrate from the circulating blood into tissues and mop up foreign material such as viruses with their abnormal surface makers (antigens)and metal debris, activating specialist white blood cells (such as T cells) that kill viruses and remove abnormal material.

研究设计

研究类型
Observational

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who have undergone Ultima TPS THRs in Norwich
  • Patients with a MoP THR under going revision.
  • Patients undergoing primary hip replacement with osteoarthritis
  • Patients with other MoM THRs undergoing revision

排除标准

  • Patients undergoing primary THR with rheumatoid arthritis or other inflammatory arthritides, or secondary to infection

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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