Investigating hearing loss in patients with metal-on-metal hip implants
Official title: Ototixicity in Patients With a Metal-on-Metal Hip Arthroplasty
Run by Reinier Haga Orthopedisch Centrum · NCT06885411 · Data updated 2026-11-12
This study is testing whether people with metal-on-metal hip implants experience hearing loss due to metal exposure in their blood.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Reinier Haga Orthopedisch Centrum Academic / other |
| Locations | 1 site (Delft) |
| Status | Recruiting |
| Started | February 1, 2023 |
| Main results expected | December 1, 2025 |
| Study ends | December 1, 2025 |
| Registry record updated | March 20, 2025 |
| Trial ID | NCT06885411 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients who have received metal-on-metal hip implants and are willing to participate while being proficient in the Dutch language.
✕Probably not a fit
Patients who have had previous ENT surgery or have existing ENT pathology may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the prevalence of hearing loss in patients who have undergone metal-on-metal (MoM) hip arthroplasty. It will evaluate the relationship between plasma metal concentrations, specifically cobalt and chromium, and the incidence of ototoxicity. The study will involve patients from various clinics who have received MoM implants, focusing on their auditory health and potential complications related to metal exposure. Participants will be monitored for their hearing capabilities and metal levels in their blood.
Why it matters
Potential benefit: If successful, this study could provide insights into the risks of hearing loss associated with metal-on-metal hip implants, leading to better patient management and device selection.
How similar studies have gone: While there have been studies on metal-on-metal implants, the specific focus on ototoxicity and its correlation with plasma metal concentrations is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * all MoM patients from the different clinics * revision MoM * willing to participate * speak/write the Dutch language Exclusion Criteria: * Not willing to participate * previous ENT surgery or ENT pathology
Where it's running
-
Reinier de Graaf Ziekenhuis
Delft, Netherlands Recruiting
Study contacts
- Study coordinator: Nina Mathijssen, Dr
- Email: n.mathijssen@rhoc.nl
- Phone: +31(0)79 206 5583
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.