Si-Bone ((SIBN)) announced an update on their ongoing clinical study.
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SI-BONE, Inc. is conducting a clinical study titled ‘Pelvic Fixation and Fusion During Multilevel Spinal Surgery’ to evaluate the safety, performance, and effectiveness of the iFuse Bedrock Granite in patients undergoing spinal fusion surgery with pelvic fixation. This study aims to provide crucial data that could influence treatment protocols for spinal conditions.
The intervention being tested is the iFuse Bedrock Granite Implant System, a device designed for spinal surgery involving pelvic fixation and fusion. Its purpose is to enhance surgical outcomes by providing robust support during spinal fusion procedures.
The study is observational, following a cohort of participants prospectively. It does not involve random allocation or masking, focusing instead on observing outcomes in a real-world setting. The primary aim is to gather data on the device’s performance over time.
The study began on November 28, 2022, with an estimated completion date of May 8, 2025. These dates are significant as they outline the timeline for data collection and analysis, which can impact the timing of potential market releases or updates.
This clinical update could positively influence SI-BONE’s stock performance, as successful results may boost investor confidence and market position. It also places SI-BONE in a competitive stance within the spinal surgery device industry, potentially affecting competitors.
The study is currently ongoing, with further details available on the ClinicalTrials portal.