Ototoxic Hearing LossGODMOTHERNCT06885411
Ototoxicity in Patients With MoM Hip Bearings
An observational study of Ototoxic Hearing Loss and Cobalt Poisoning, run by Reinier Haga Orthopedisch Centrum at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ototoxic Hearing Loss, Cobalt Poisoning, Chromium Causing Toxic Effect
- What is being tested?
- metal-on-metal hip arthroplasty
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Feb 2023to 1 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients in the participating hospitals with a MoM hip arthroplasty or a revised MoM hip arthroplasty.
Who may be able to join
- all MoM patients from the different clinics
- revision MoM
- willing to participate
- speak/write the Dutch language
Who cannot join
- Not willing to participate
- previous ENT surgery or ENT pathology
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Reinier de Graaf Ziekenhuis
Delft
Maarten Koper, PhD, +31(0)79 206 5583, m.koper@rhoc.nl
About this study
Official title: Ototixicity in Patients With a Metal-on-Metal Hip Arthroplasty
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.
- Conditions
- Ototoxic Hearing Loss, Cobalt Poisoning, Chromium Causing Toxic Effect, Arthroplasty Complications
- Being tested
- metal-on-metal hip arthroplasty
- Keywords
- Metal-on-Metal implant; Cobalt; Chromium; Hip arthroplasty; auditory system; Otoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metal-on-metal hip arthroplastyOther
Cobalt and chromium release from metal-on-metal hip arthroplasties.
| Study group | Role | What they receive |
|---|---|---|
| Arthroplasty patients | Patients with a (revised) metal-on-metal hip arthroplasty Receives: Other: metal-on-metal hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Participants will perform a hearing test once during the study, during a visit of the outpatient clinic.
Secondary outcomes (5)
Age
Age will be determined once, during a visit of the outpatient clinic
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Chromium serum concentration will be determined once for each participant, at time of the visit of the outpatient clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Feb 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ototoxic Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Reinier Haga Orthopedisch Centrum
- Sponsor type
- University, hospital or other
- Collaborators
- Reinier de Graaf Groep, Erasmus Medical Center, Zuyderland Medical Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885411
- Sponsor's protocol ID
- OC-2021-012
- Acronym
- GODMOTHER
- Status last verified
- Mar 2025
- First submitted
- 20 Nov 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ototixicity in Patients With a Metal-on-Metal Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06885411
- Acronym / sponsor ID
- GODMOTHER / OC-2021-012
- Conditions
- Ototoxic Hearing Loss, Cobalt Poisoning, Chromium Causing Toxic Effect, Arthroplasty Complications
- Keywords
- Metal-on-Metal implant; Cobalt; Chromium; Hip arthroplasty; auditory system; Otoxicity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Reinier Haga Orthopedisch CentrumUniversity, hospital or other
- Collaborators
- Reinier de Graaf Groep, Erasmus Medical Center, Zuyderland Medical Centre
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthroplasty patients | – | Other: metal-on-metal hip arthroplastyPatients with a (revised) metal-on-metal hip arthroplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients in the participating hospitals with a MoM hip arthroplasty or a revised MoM hip arthroplasty.
Key inclusion criteria (4 listed)
- all MoM patients from the different clinics
- revision MoM
- willing to participate
- speak/write the Dutch language
Key exclusion criteria (2 listed)
- Not willing to participate
- previous ENT surgery or ENT pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metal-on-metal hip arthroplastyCobalt and chromium release from metal-on-metal hip arthroplasties. | Other | Arthroplasty patients |
Primary outcome
Mid frequency hearing loss
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
5 secondary outcomes
Age
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.
Time frame: The questionnaire will be completed once by each participant, at time of the visit of the outpatient clinic
BMI
Time frame: Lenght and weight will be determined once for each participant, at time of the visit of the outpatient clinic
Cobalt serum concentration
Time frame: Cobalt serum concentration will be determined once for each participant, at time of the visit of the outpatient clinic
Chromium serum concentration
Time frame: Chromium serum concentration will be determined once for each participant, at time of the visit of the outpatient clinic
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Ototoxic Hearing Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ototoxic Hearing Loss and Cobalt Poisoning, run by Reinier Haga Orthopedisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina Mathijssen, Dr (+31(0)79 206 5583, n.mathijssen@rhoc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mid frequency hearing loss (time frame: Participants will perform a hearing test once during the study, during a visit of the outpatient clinic.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.