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Metal-ions in Patients With the PEEK HD Coupling Mechanism of the Knee
Sponsor: Leiden University Medical Center
Summary
The goal of this observational study is to evaluate the changes of serum metal ion (Cobalt and Chrome) levels at 0, 3-6, 12, and 24 months postoperative in patients receiving a MUTARS mega-prostheses of the knee with a PEEK HD coupling mechanism. The main question(s) to answer are: • \[what is the change in serum level metal ions (Cobalt and Chrome) in patients receiving a primary MUTARS knee endoprosthesis with the PEEK HD coupling mechanism \] • \[what is the change in serum level metal ions (Cobalt and Chrome) in patients with a MoM coupling mechanism revised to the PEEK HD coupling mechanism\]. Participants will be asked to fill out functional outcome measures during the period under study.
Official title: Systemic Metal Ion Concentrations in Patients With a PEEK HD Coupling Mechanism in Modular Mega-prostheses of the Knee; a Prospective Cohort Pilot Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2023-06
Completion Date
2028-06
Last Updated
2023-06-08
Healthy Volunteers
Not specified
Conditions
Interventions
Blood sample analysis
Blood sample analysis on Cobalt and Chrome will be performed during the period under study.
Locations (1)
Leiden University Medical Center
Leiden, South Holland, Netherlands