About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
all MoM patients from the different clinics
revision MoM
willing to participate
speak/write the Dutch language
Disqualifiers
Not willing to participate
previous ENT surgery or ENT pathology
Trial population
All patients in the participating hospitals with a MoM hip arthroplasty or a revised MoM hip arthroplasty.
Trial design
Cohort
Prospective
Treatments tested in this trial
metal-on-metal hip arthroplasty
Other interventionCobalt and chromium release from metal-on-metal hip arthroplasties.
Treatment groups
Trial outcomes
Primary outcomes
Mid frequency hearing loss
Mid frequency hearing loss will be determined once with a conventional pure-tone audiometry test during a visit of the outpatient clinic
Secondary outcomes
Age
Age will be determined once, during a visit of the outpatient clinic
subjective general health and subjective hearing loss measured with the Amsterdam Inventory for Auditory Disability and Handicap questionnaire.
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
BMI
BMI will be dermined once, at time of measurement weight and height will be combined to report BMI in kg/m\^2
Cobalt serum concentration
Cobalt serum concentration will be dermined once, throught venipuncture, at time of the visit of the outpatient clinic.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Reinier Haga Orthopedisch Centrum
Lead sponsor
Reinier de Graaf Groep
Collaborator
Erasmus Medical Center
Collaborator
Zuyderland Medical Centre
Collaborator