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| Name | Class |
|---|---|
| Reinier de Graaf Groep | OTHER |
| Erasmus Medical Center | OTHER |
| Zuyderland Medical Centre | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arthroplasty patients | Patients with a (revised) metal-on-metal hip arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metal-on-metal hip arthroplasty | Other | Cobalt and chromium release from metal-on-metal hip arthroplasties. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Participants will perform a hearing test once during the study, during a visit of the outpatient clinic. |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Age will be determined once, during a visit of the outpatient clinic | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients in the participating hospitals with a MoM hip arthroplasty or a revised MoM hip arthroplasty.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nina Mathijssen, Dr | Contact | +31(0)79 206 5583 | n.mathijssen@rhoc.nl | |
| Maarten Koper, dr. | Contact | +31(0)79 206 5583 | m.koper@rhoc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reinier de Graaf Ziekenhuis | Recruiting | Delft | Netherlands |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2022 | Jan 10, 2023 | Prot_SAP_000.pdf |
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Bloodsample to determine cobalt and chromium concentrations
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 |
| 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 | 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. | 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. | Chromium serum concentration will be determined once for each participant, at time of the visit of the outpatient clinic |