Arthroplasty Complications, Chromium Causing Toxic Effect, Cobalt Poisoning, Ototoxic Hearing Loss
Conditions
Keywords
Metal-on-Metal implant; Cobalt; Chromium; Hip arthroplasty; auditory system; Otoxicity
Brief summary
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.
Interventions
OTHERmetal-on-metal hip arthroplasty
Cobalt and chromium release from metal-on-metal hip arthroplasties.
Sponsors
Reinier de Graaf Groep
Erasmus Medical Center
Zuyderland Medical Centre
Reinier Haga Orthopedisch Centrum
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mid frequency hearing loss | 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
| Measure | Time frame | Description |
|---|---|---|
| Age | 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 |
| subjective general health and subjective hearing loss measured with the Amsterdam Inventory for Auditory Disability and Handicap questionnaire. | 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 |
| BMI | 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 |
| Cobalt serum concentration | 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. |
| Chromium serum concentration | 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. |
Countries
Netherlands
Contacts
Primary ContactNina Mathijssen, Dr
Backup ContactMaarten Koper, dr.
Outcome results
None listed