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

NCT05893602 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-06-08

No results posted yet for this study

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.

Conditions

  • Mutars
  • Modular Universal Tumor And Revision System
  • Metal-ions
  • Tumor Prosthesis
  • Megaprosthesis
  • PEEK-HD Coupling Mechanism
  • Knee Endoprosthesis

Interventions

OTHER

Blood sample analysis

Blood sample analysis on Cobalt and Chrome will be performed during the period under study.

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05893602 on ClinicalTrials.gov