NCT06699134

Hi-Fatigue G Bone Cement Retrospective Study

Evaluation of Hi-Fatigue G Bone Cement With Gentamicin A Retrospective Data Collection

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this retrospective monocentric study is to collect survivorship and clinical data confirming safety, performance and clinical benefits for the Hi-Fatigue G Bone Cement. The assessments will include: * Radiological analysis performed at different time points according to the standard of care of the hospital * Implant survivorship and safety based on removal of a study device * Patient reported outcome measures (PROMs) Primary endpoint: Assessment of radiolucent lines around the components (tibial, femoral, acetabular) at 5 years (in accordance with the hospital standard of care). Secondary endpoints: * Evaluation of implant survivorship and safety by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. * Evaluation of PROMs * Obtain information regarding the cementing technique and handling of the cement, if available

Conditions

• Total Hip and Knee Arthroplasties

Interventions

Type	Name	Description
DEVICE	Total knee arthroplasty	Primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant
DEVICE	Total Hip arthroplasty	Primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant

Timeline

• Start date: 2024-11-19
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2024-11-21
• Last updated: 2025-12-02

Locations

1 site across 1 country: Germany