Ototoxicity in Patients With MoM Hip Bearings

NCT ID: NCT06885411

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Ototoxic Hearing Loss Cobalt Poisoning Chromium Causing Toxic Effect Arthroplasty Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Arthroplasty patients

Patients with a (revised) metal-on-metal hip arthroplasty

metal-on-metal hip arthroplasty

Intervention Type OTHER

Cobalt and chromium release from metal-on-metal hip arthroplasties.

Interventions

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metal-on-metal hip arthroplasty

Cobalt and chromium release from metal-on-metal hip arthroplasties.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Reinier de Graaf Groep

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role collaborator

Zuyderland Medical Centre

OTHER

Sponsor Role collaborator

Reinier Haga Orthopedisch Centrum

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Reinier de Graaf Ziekenhuis

Delft, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Nina Mathijssen, Dr

Role: CONTACT

+31(0)79 206 5583

Maarten Koper, dr.

Role: CONTACT

+31(0)79 206 5583

Facility Contacts

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Maarten Koper, PhD

Role: primary

+31(0)79 206 5583

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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OC-2021-012

Identifier Type: -

Identifier Source: org_study_id

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