Ototoxicity in patients with Metal-on-Metal hip Arthroplasties

Ototoxicity in patients with Metal-on-Metal hip Arthroplasties - Ototoxicity with Metal-on-Metal hip bearings

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56425

Enrollment

450

Registered

2022-08-05

Start date

2023-03-24

Completion date

Unknown

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hearing loss ototoxicity

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All MoM patients from the different clinics Revision MoM Willing to participate Speak/write the Dutch language.

Exclusion criteria

Exclusion criteria: Not willing to participate Previous ENT surgery or ENT pathology

Design outcomes

Primary

Measure	Time frame
To assess the prevalence of damage to the auditory system in patients with a Metal-on-Metal or revised Metal-on-Metal bearing, especially regarding mid frequency hearing loss. A distinction will be made between prevalence in patients with high plasma cobalt or chromium levels and patients with low plasma cobalt and chromium levels.	—

Secondary

Measure	Time frame
To assess which factors are associated with damage to the auditory system (We will only perform this if possible, if we have enough cases with hearing loss). o Factors of interest: highest known cobalt plasma concentration, highest known chromium plasma concentration, type of prosthesis, age, work in a noisy environment, presence of ARDM, revision o Patients will be asked to complete the hearing questionnaire as well as the Metal-on-Metal Prosthesis Questionnaire for Assessing General Health in order determine the general health of these patients and subjective hearing loss.	—

Measure

Time frame

To assess which factors are associated with damage to the auditory system (We will only perform this if possible, if we have enough cases with hearing loss). o Factors of interest: highest known cobalt plasma concentration, highest known chromium plasma concentration, type of prosthesis, age, work in a noisy environment, presence of ARDM, revision o Patients will be asked to complete the hearing questionnaire as well as the Metal-on-Metal Prosthesis Questionnaire for Assessing General Health in order determine the general health of these patients and subjective hearing loss.

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Countries

Netherlands

Outcome results