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临床试验/NCT01493375
NCT01493375暂停不适用

Surgical Field Bacterial Contamination in Primary Hip and Knee Replacement Surgery

Northern Orthopaedic Division, Denmark1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
60
试验地点
1
主要终点
Contamination of the operation area

研究概览

简要总结

In Denmark, approximately 13,000 operations are carried out every year. Prosthetic infection is a very serious condition and despite extensive prophylactic measures, prosthetic infections appear in 1-2 percent of the operated patients.

It is difficult to diagnose prosthetic infection with the techniques applied so far and incorrect diagnosis might imply unnecessary reoperations as well as unnoticed infections might lead to prolonged pain and invalidity.

The purpose of this study is to examine the value of these three techniques applied as a supplement to the existing technology and on this basis to prepare an algorithm for the examination of joint prosthesis infection.

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

  • Patients who have been through an alloplastic operation in hip og knee.

排除标准

  • Patients with cancer or a bilateral disease
  • Former patients who have been through an operation with implants in hip or knee.
  • Patients who might be infected in the joint due to operation in hip or knee.
  • Lack of informed consent or inability to read/understand Danish

结局指标

主要结局

Contamination of the operation area

时间窗: 12 months

We want to examine the existence of contamination before an operation in hip and knee. Furthermore, we want to examine the contamination to achieve better knowledge of the bacterial combination.

次要结局

  • Description of the bacterial culture(12 months)

研究者

发起方
Northern Orthopaedic Division, Denmark
申办方类型
Other
责任方
Sponsor

研究点 (1)

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