Clinical trial Recruiting at 1 site Observational

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.

More Arthroplasty Complications trials

Quick facts

Study typeObservational
SexAll
Enrollment200 (estimated)
SponsorReinier Haga Orthopedisch Centrum
Academic / other
Locations1 site (Delft)
StatusRecruiting
StartedFebruary 1, 2023
Main results expectedDecember 1, 2025
Study endsDecember 1, 2025
Registry record updatedMarch 20, 2025
Trial IDNCT06885411 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.