Condition: Total Hip and Knee Arthroplasties · Sponsor: Zimmer Biomet
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
This description comes directly from the study's public registry record.
Miguel Correa-Tapia · +41791522905 · Miguel.CorreaTapia@zimmerbiomet.com
Linda Meijer · +31657933741 · linda.meijer@zimmer.com
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| Klinikum Weiden | Weiden, Bavaria, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06699134