Actively Recruiting

All Genders
Healthy Volunteers
ID06885411

Ototoxicity in Patients With a Metal-on-Metal Hip Arthroplasty

Led by Reinier Haga Orthopedisch Centrum · Updated on 2025-03-20

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

R

Reinier Haga Orthopedisch Centrum

Lead Sponsor

R

Reinier de Graaf Groep

Collaborating Sponsor

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

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • All patients with metal-on-metal hip arthroplasty from the participating clinics
  • Patients who have had a revision of a metal-on-metal hip arthroplasty
  • Willingness to participate in the study
  • Ability to speak and write Dutch
Not Eligible

You will not qualify if you...

  • Not willing to participate in the study
  • History of ear, nose, or throat (ENT) surgery or ENT disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo a hearing test and complete questionnaires to assess hearing loss and general health, along with measurements of age, BMI, and metal serum concentrations.

1 visit (outpatient clinic)

Trial Site Locations

Total: 1 location

1

Reinier de Graaf Ziekenhuis

Delft, Netherlands

Actively Recruiting

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Research Team

N

Nina Mathijssen, Dr

M

Maarten Koper, dr.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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