Metal-ions in Patients With the PEEK HD Coupling Mechanism of the Knee

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Jun 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the levels of metal ions, specifically cobalt and chrome, in the blood of patients who receive a type of knee replacement called a MUTARS mega-prosthesis, which uses a special coupling mechanism known as PEEK HD. The researchers want to find out how these metal ion levels change over time after surgery, checking at 0, 3-6, 12, and 24 months. They are particularly interested in two groups of patients: those getting the PEEK HD knee replacement for the first time and those who are having a previous knee replacement revised to use the PEEK HD mechanism.

To participate in this study, you need to be at least 18 years old and either be receiving a MUTARS knee replacement with the PEEK HD mechanism or be undergoing a revision of a previous MUTARS knee replacement. It's important that you can provide informed consent and that you don’t have certain medical conditions or previous exposures that might affect the study results. Participants will be asked to complete surveys about their knee function during the study. This trial is currently not recruiting participants, but it aims to gather important information about how this type of knee replacement impacts metal ion levels in the body.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • In order to be eligible to participate in this study, a subject must meet all of the following criteria: The patient
• • 1. is 18 years of age or older
• • 2. receives a MUTARS knee replacement with PEEK HD coupling mechanism, or undergoes a revision (for any reason) of a MUTARS knee replacement during which the MoM coupling mechanism is revised for a PEEK HD coupling mechanism
• • 3. Is able to give informed consent
• Exclusion Criteria:
• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• • 1. Anamnestic use of metal containing nutritional supplements or medications
• • 2. Contact with metal ions in the work environment
• • 3. Renal insufficiency defined as an eGFR\<60
• • 4. Presence of implants containing Cobalt and Chrome (including non-orthopaedic implants such as stents and dental implants)