Zimmer Biomet Holdings ((ZBH)) announced an update on their ongoing clinical study.
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Zimmer Biomet Holdings is conducting a study titled ‘Performance, Safety and Clinical Benefits of a Noble Metal Alloy-coated Intramedullary Nail: a Multicenter, Prospective Trial With a Retrospective Control.’ The study aims to compare fracture-related infection rates between the ZNN Bactiguard Tibia and conventional uncoated titanium-alloy nails 12 months post-tibia fracture fixation. It also seeks to confirm the safety, performance, and clinical benefits of the ZNN Bactiguard implant.
The intervention being tested is the ZNN Bactiguard tibia, a device designed for tibia fracture fixation. The study involves two groups: an investigational group receiving the ZNN Bactiguard tibia device and a control group with data collected retrospectively from patients who received uncoated titanium-alloy nails.
This observational study follows a case-control model with a prospective time perspective. It does not involve any specific allocation, intervention model, or masking, focusing primarily on evaluating the device’s effectiveness and safety.
The study began on July 16, 2021, with the last update submitted on December 16, 2024. These dates are crucial as they mark the study’s progression and the latest data availability, which investors can track for ongoing developments.
The study’s outcomes could significantly impact Zimmer Biomet’s market position by potentially enhancing its product portfolio with a safer, more effective tibia fixation device. This could positively influence stock performance and investor sentiment, especially if the results demonstrate superior infection prevention compared to competitors.
The study is currently recruiting, with further details available on the ClinicalTrials portal.