Investigating hearing loss in patients with metal-on-metal hip implants
Ototixicity in Patients With a Metal-on-Metal Hip Arthroplasty
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Reinier Haga Orthopedisch Centrum Academic / other |
| Locations | 1 site (Delft) |
| Trial ID | NCT06885411 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who have had previous ENT surgery or have existing ENT pathology may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Delft
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.