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Study of Hearing Loss and Metal Levels in Patients With Metal-on-Metal Hip Replacements
Led by Reinier Haga Orthopedisch Centrum · Updated on 2025-03-20
200
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This observational study aims to understand hearing loss ototoxicity in patients who have received a metal-on-metal MoM hip arthroplasty. It specifically seeks to determine how common hearing loss is among patients with different levels of metal concentrations in their blood, focusing on cobalt and chromium. The study is sponsored by Reinier Haga Orthopedisch Centrum and involves patients who have had primary or revised MoM hip implants. Participants include patients with metal-on-metal hip arthroplasties, and the study looks at the release of cobalt and chromium metals from these implants. There is no treatment or intervention administered instead, the study collects data during a single outpatient clinic visit. This visit involves hearing tests and blood sample collection to measure metal concentrations. During the outpatient clinic visit, participants will have a hearing test to assess mid-frequency hearing loss. They will also complete a questionnaire about their general health and subjective hearing ability. Additional measurements include age, body mass index BMI, and blood levels of cobalt and chromium. The study aims to gather this information once per participant to evaluate the relationship between metal exposure and hearing loss.
CONDITIONS
Brief Title
Ototoxicity in Patients With MoM Hip Bearings
Research Team
N
Nina Mathijssen, Dr
M
Maarten Koper, dr.
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