Ototoxicity in Patients With MoM Hip Bearings (GODMOTHER)

March 17, 2025 updated by: Reinier Haga Orthopedisch Centrum

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

The goal of this observational study is to learn about ototoxicity in patients with a MoM hip arthroplasty. The main question it aims to answer is:

• What is the prevalence of hearing loss in patients with high and low plasma metal concentrations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Maarten Koper, dr.
  • Phone Number: +31(0)79 206 5583
  • Email: m.koper@rhoc.nl

Study Locations

  • Netherlands
      • Delft, Netherlands
        • Recruiting
        • Reinier de Graaf Ziekenhuis
        • Contact:
          • Maarten Koper, PhD
          • Phone Number: +31(0)79 206 5583
          • Email: m.koper@rhoc.nl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All patients in the participating hospitals with a MoM hip arthroplasty or a revised MoM hip arthroplasty.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arthroplasty patients
Patients with a (revised) metal-on-metal hip arthroplasty
Other: metal-on-metal hip arthroplasty
Cobalt and chromium release from metal-on-metal hip arthroplasties.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mid frequency hearing loss
Time Frame: Participants will perform a hearing test once during the study, during a visit of the outpatient clinic.
Mid frequency hearing loss will be determined once with a conventional pure-tone audiometry test during a visit of the outpatient clinic
Participants will perform a hearing test once during the study, during a visit of the outpatient clinic.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: Age will be determined once for each participant, at time of the visit of the outpatient clinic
Age will be determined once, during a visit of the outpatient clinic
Age will be determined once for each participant, at time of the visit of the outpatient clinic
subjective general health and subjective hearing loss measured with the Amsterdam Inventory for Auditory Disability and Handicap questionnaire.
Time Frame: The questionnaire will be completed once by each participant, at time of the visit of the outpatient clinic
The subjective general health and subjective hearing loss will be determined by Amsterdam Inventory for Auditory Disability and Handicap. The questionnaire will be completed by the participants once,at time of the visit of the outpatient clinic
The questionnaire will be completed once by each participant, at time of the visit of the outpatient clinic
BMI
Time Frame: Lenght and weight will be determined once for each participant, at time of the visit of the outpatient clinic
BMI will be dermined once, at time of measurement weight and height will be combined to report BMI in kg/m^2
Lenght and weight will be determined once for each participant, at time of the visit of the outpatient clinic
Cobalt serum concentration
Time Frame: Cobalt serum concentration will be determined once for each participant, at time of the visit of the outpatient clinic
Cobalt serum concentration will be dermined once, throught venipuncture, at time of the visit of the outpatient clinic.
Cobalt serum concentration will be determined once for each participant, at time of the visit of the outpatient clinic
Chromium serum concentration
Time Frame: Chromium serum concentration will be determined once for each participant, at time of the visit of the outpatient clinic
Chromium serum concentration will be dermined once, throught venipuncture, at time of the visit of the outpatient clinic.
Chromium serum concentration will be determined once for each participant, at time of the visit of the outpatient clinic

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reinier Haga Orthopedisch Centrum

Collaborators

Erasmus Medical Center
Reinier de Graaf Groep
Zuyderland Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OC-2021-012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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