An observational study in Ototoxic Hearing Loss, Cobalt Poisoning and Chromium Causing Toxic Effect, sponsored by Reinier Haga Orthopedisch Centrum. Recruiting at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Reinier Haga Orthopedisch Centrum · Observational
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:
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 192 observational studies indexed under Hearing Loss.
Browse Hearing Loss studies →Reinier Haga Orthopedisch Centrum is the lead sponsor of 12 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients in the participating hospitals with a MoM hip arthroplasty or a revised MoM hip arthroplasty.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with a (revised) metal-on-metal hip arthroplasty
Other: metal-on-metal hip arthroplasty
Cobalt and chromium release from metal-on-metal hip arthroplasties.
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.
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
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
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
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
Chromium serum concentration
Chromium serum concentration will be dermined once, throught venipuncture, at time of the visit of the outpatient clinic.
Time frame: Chromium serum concentration will be determined once for each participant, at time of the visit of the outpatient clinic
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Reinier Haga Orthopedisch Centrum