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Refobacin Revision-3 Bone Cement Post-Market Study

NCT06699160 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-11-25

No results posted yet for this study

Summary

The goal of this post-market study is to confirm the safety, performance and clinical benefits of the Refobacin Revision-3 Bone Cement when used in knee or hip revision surgeries. This will be done by collecting information on:

* removal of any metal components of the hip or knee implants used in combination with the cement
* frequency and incidence of adverse events
* overall pain and functional performance, subject quality of life, and radiographic parameters

Conditions

  • Revision Arthroplasty

Interventions

DEVICE

Revision arthroplasty

Hip or knee revision surgery resulting from aseptic loosening of the prosthesis and/or infection of the prosthesis by gentamicin and/or clindamycin sensitive strains.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Emilie Rohmer, Clin Op Dir · Zimmer Biomet

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2030-12-31
Completion
2030-12-31

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 NCT06699160 on ClinicalTrials.gov