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临床试验/NCT06885411
NCT06885411招募中不适用

Ototixicity in Patients With a Metal-on-Metal Hip Arthroplasty

Reinier Haga Orthopedisch Centrum1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年2月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Mid frequency hearing loss

研究概览

简要总结

The goal of this observational study is to learn about ototoxicity in patients with a MoM hip arthroplasty. The main question it aims to answer is:

• What is the prevalence of hearing loss in patients with high and low plasma metal concentrations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • all MoM patients from the different clinics
  • revision MoM
  • willing to participate
  • speak/write the Dutch language

排除标准

  • Not willing to participate
  • previous ENT surgery or ENT pathology

结局指标

主要结局

Mid frequency hearing loss

时间窗: Participants will perform a hearing test once during the study, during a visit of the outpatient clinic.

Mid frequency hearing loss will be determined once with a conventional pure-tone audiometry test during a visit of the outpatient clinic

次要结局

  • Age(Age will be determined once for each participant, at time of the visit of the outpatient clinic)
  • subjective general health and subjective hearing loss measured with the Amsterdam Inventory for Auditory Disability and Handicap questionnaire.(The questionnaire will be completed once by each participant, at time of the visit of the outpatient clinic)
  • BMI(Lenght and weight will be determined once for each participant, at time of the visit of the outpatient clinic)
  • Cobalt serum concentration(Cobalt serum concentration will be determined once for each participant, at time of the visit of the outpatient clinic)
  • Chromium serum concentration(Chromium serum concentration will be determined once for each participant, at time of the visit of the outpatient clinic)

研究者

发起方
Reinier Haga Orthopedisch Centrum
申办方类型
Other
责任方
Sponsor

研究点 (1)

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