Retrospective Study of Hi-Fatigue G Bone Cement Use in Total Hip and Knee Replacement with Zimmer Biomet Implants

What this Trial Is About

Researchers are collecting retrospective data to evaluate the safety, performance, and clinical benefits of the Hi-Fatigue G Bone Cement used in total knee and hip replacements with Zimmer Biomet implants. The study aims to confirm implant survivorship and clinical outcomes by analyzing radiological images and patient-reported measures over time. This observational study focuses on patients who have already undergone primary total knee or hip arthroplasty with this specific bone cement. The study includes patients who received primary total knee or hip replacements using Hi-Fatigue G Bone Cement combined with Zimmer Biomet implants. Data collection involves radiological evaluations at various time points following the hospitals standard care, focusing on radiolucent lines around the implant components at 5 years. The study also monitors implant survivorship, safety by tracking adverse events related to the implant or procedure, and gathers information on the cementing technique and handling when available. Participants will have their radiographic images reviewed from enrollment through 5 years after surgery. Patient-reported outcome measures PROMs will be collected to assess clinical benefits, along with monitoring any implant removals or adverse events. The study relies on standard hospital follow-up visits and evaluations, including X-rays and clinical scores, to gather comprehensive data on the implants performance and patient experience. Total participation time spans from enrollment to the 5-year postoperative follow-up.

Hi-Fatigue G Bone Cement Retrospective Study