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
- 是
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
研究点 (1)
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