To evaluate the prevalence of ocular-vestibular symptoms in patients with a (revised) MoM hip prosthesis. Our hypothesis is that patients with high plasma metal ion levels have a higher prevalence of damage to the auditory system.
ID
Source
Brief title
Condition
- Hearing disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Patients with a Metal-on-Metal (MoM) hip prosthesis have an increased risk of
elevated serum metal ions. High plasma levels of cobalt (Co) and chromium (Cr)
are associated with local and systemic adverse reactions. Ototoxicity, such as
hearing loss, tinnitus and dizziness, could be related to high plasma levels of
these ions.
Study objective
To evaluate the prevalence of ocular-vestibular symptoms in patients with a
(revised) MoM hip prosthesis. Our hypothesis is that patients with high plasma
metal ion levels have a higher prevalence of damage to the auditory system.
Study design
Multi-centre cohort study.
Study burden and risks
The burden is primarily time, one/two (online/home) questionnaire(s) and one
visit to the outpatient ENT department. During that visit we will also obtain a
blood sample.*
Reinier de Graafweg 5
Delft 2625 AD
NL
Reinier de Graafweg 5
Delft 2625 AD
NL
Listed location countries
Age
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
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL79241.058.22 |