Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2023-02-01
2025-12-01
Brief Summary
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• What is the prevalence of hearing loss in patients with high and low plasma metal concentrations.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Arthroplasty patients
Patients with a (revised) metal-on-metal hip arthroplasty
metal-on-metal hip arthroplasty
Cobalt and chromium release from metal-on-metal hip arthroplasties.
Interventions
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metal-on-metal hip arthroplasty
Cobalt and chromium release from metal-on-metal hip arthroplasties.
Eligibility Criteria
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Inclusion Criteria
* revision MoM
* willing to participate
* speak/write the Dutch language
Exclusion Criteria
* previous ENT surgery or ENT pathology
ALL
Yes
Sponsors
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Reinier de Graaf Groep
OTHER
Erasmus Medical Center
OTHER
Zuyderland Medical Centre
OTHER
Reinier Haga Orthopedisch Centrum
OTHER
Responsible Party
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Locations
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Reinier de Graaf Ziekenhuis
Delft, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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OC-2021-012
Identifier Type: -
Identifier Source: org_study_id
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