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NCT05893602

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

Sponsor: Leiden University Medical Center

View on ClinicalTrials.gov

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

Interventions

OTHER

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