Orthofix International ((OFIX)) announced an update on their ongoing clinical study.
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Orthofix International is conducting a study titled ‘A Prospective Post-Market Historically Controlled Open-Label Study to Assess the Efficacy of Virtuos in Lumbar Fusion.’ The study aims to evaluate the effectiveness of a cellular-based allograft bone graft, Virtuos, in lumbar spinal fusion for patients with degenerative disc disease. This research is significant as it could offer new insights into improving spinal fusion outcomes.
The intervention being tested is the Virtuos bone graft, a cellular-based allograft designed to enhance spinal fusion procedures. It is intended to aid in the fusion process for patients undergoing lumbar spinal fusion at one or two levels.
The study is observational, utilizing a cohort model with a prospective time perspective. There is no allocation or masking involved, as the study is open-label. The primary purpose is to observe the efficacy of the Virtuos bone graft in a real-world setting.
The study began on November 7, 2024, and is currently enrolling by invitation. The last update was submitted on April 1, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates for stakeholders.
This update could positively impact Orthofix’s stock performance and investor sentiment, as successful results may enhance the company’s market position in the spinal fusion industry. Competitors in the orthopedic sector will likely monitor these developments closely.
The study is ongoing, with further details available on the ClinicalTrials portal.