Clinical Trial

Hi-Fatigue G Bone Cement Retrospective Study

Recruiting
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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
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-11-19; most recent amendment 2025-12-01.
Trial Details
NCT Number NCT06699134
Lead Sponsor Zimmer Biomet
Conditions Total Hip and Knee Arthroplasties
Enrollment 90 participants
Start Date 2024-11-19
Primary Completion 2026-10 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2025-12-02