NCT06699160

Refobacin Revision-3 Bone Cement Post-Market Study

Post Market Clinical Follow-up Study on the Refobacin Revision-3 Bone Cement and Its Instrumentation

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Multicenter, retrospective and prospective, non-controlled Post-Market Clinical Follow-Up (PMCF) study involving orthopedic surgeons skilled in knee or hip arthroplasty procedures. Patients will be enrolled prospectively or retrospectively (minimum 3 years after their surgery, depending on the availability of the data.

Conditions

• Revision Arthroplasty

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2024-11-21
• Last updated: 2025-11-25

Locations

1 site across 1 country: Netherlands