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临床试验/ACTRN12608000394347
ACTRN12608000394347已完成未知

Prospective consecutive multi-centre 12 month follow up of 50 patients undergoing single level Lumbar Disc Arthroplasty, assessing the change in Chrome and Cobalt metal ions over time

Stryker South Pacific0 个研究点目标入组 50 人开始时间: 2008年8月4日最近更新:
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适应症

试验速览

阶段
未知
状态
已完成
入组人数
50
研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment

入排标准

年龄范围
18 Years 至 60 Years（—）
性别
All

入选标准

  • •1) A greater than 6 month history of degenerative disc disease prior to surgery
  • •2) A greater than 6 month history of conservative treatment prior to surgery
  • •3) Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up
  • •4) Patients who are capable of, and have given informed consent to their participation in the study.

排除标准

  • •1) Patients with previous destabilising spinal surgery or prior spinal fusion
  • •2) Patients with advanced spinal facet arthrosis
  • •3) Pregnancy
  • •4) Patients with a metal allergy
  • •5) Patients with Spondylolisthesis
  • •6) Patients with osteoporosis
  • •7) patients with renal impairment
  • •8) patients that have any other kind of metallic implants
  • •9) Patients taking health supplements with Chrome or Cobalt
  • •10) Metabolic disorders that may affect Chromium and Cobalt metabolism

研究者

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