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Recruiting

NCT Number: NCT06885411

Ototoxicity in Patients With MoM Hip Bearings

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.

Recruiting

Interested in participating?

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metal-on-metal hip arthroplasty

Other

Cobalt and chromium release from metal-on-metal hip arthroplasties.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maarten Koper, dr.

CONTACT

[email protected]

+31(0)79 206 5583

Nina Mathijssen, Dr

CONTACT

[email protected]

+31(0)79 206 5583

Sponsors and collaborators

Lead sponsor

Reinier Haga Orthopedisch Centrum

Other

Collaborators

  • Erasmus Medical Center
  • Reinier de Graaf Groep
  • Zuyderland Medical Centre

Registry information

Official study title

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

Acronym: GODMOTHER

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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