Reinier de Graaf Ziekenhuis
Delft, Netherlands
Location status: Recruiting
NCT Number: NCT06885411
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.
Interested in participating?
Request InfoAll sexes
Observational
Delft, Netherlands
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cobalt and chromium release from metal-on-metal hip arthroplasties.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Maarten Koper, dr.
CONTACT
Nina Mathijssen, Dr
CONTACT
Reinier Haga Orthopedisch Centrum
Other
Ototixicity in Patients With a Metal-on-Metal Hip Arthroplasty
Acronym: GODMOTHER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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