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Hi-Fatigue G Bone Cement Retrospective Study
Sponsor: Zimmer Biomet
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
Official title: Evaluation of Hi-Fatigue G Bone Cement With Gentamicin A Retrospective Data Collection
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
90
Start Date
2024-11-19
Completion Date
2026-10
Last Updated
2025-12-02
Healthy Volunteers
No
Conditions
Interventions
Total knee arthroplasty
Primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant
Total Hip arthroplasty
Primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant
Locations (1)
Klinikum Weiden
Weiden, Bavaria, Germany