Ototoxicity in Patients With MoM Hip Bearings

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorReinier Haga Orthopedisch Centrum

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • metal-on-metal hip arthroplasty

    Other intervention

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Arthroplasty patients1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Participants will perform a hearing test once during the study, during a visit of the outpatient clinic.

Secondary outcomes

1

Age

Age will be determined once, during a visit of the outpatient clinic

Time frame
Age will be determined once for each participant, at time of the visit of the outpatient clinic
2

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

Time frame
The questionnaire will be completed once by each participant, at time of the visit of the outpatient clinic
3

BMI

BMI will be dermined once, at time of measurement weight and height will be combined to report BMI in kg/m\^2

Time frame
Lenght and weight will be determined once for each participant, at time of the visit of the outpatient clinic
4

Cobalt serum concentration

Cobalt serum concentration will be dermined once, throught venipuncture, at time of the visit of the outpatient clinic.

Time frame
Cobalt serum concentration will be determined once for each participant, at time of the visit of the outpatient clinic

Other outcomes

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