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Ototoxicity in Patients With MoM Hip Bearings (GODMOTHER)

R

Reinier Haga Orthopedisch Centrum

Status

Enrolling

Conditions

Cobalt Poisoning
Ototoxic Hearing Loss
Chromium Causing Toxic Effect
Arthroplasty Complications

Treatments

Other: metal-on-metal hip arthroplasty

Study type

Observational

Funder types

Other

Identifiers

NCT06885411
OC-2021-012

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Arthroplasty patients
Description:
Patients with a (revised) metal-on-metal hip arthroplasty
Treatment:
Other: metal-on-metal hip arthroplasty

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Maarten Koper, dr.; Nina Mathijssen, Dr

Data sourced from clinicaltrials.gov

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