SIJ Stabilization in Long Fusion to the Pelvis
SIJ Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial
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Clinical Trial Information
Trial Contact: Carlo, Charlene S; Botsford, Ashley; Monserrate, Francheska
Trial Phone: 321.841.1324 ; 321.841.7550 ; 321-841-4717
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IRB No: WCG IRB 520190262
Protocol Abbrev: SILVIA
Principal Investigator: Virgilio Matheus, MD, FACS
Phase: Device: Category N/A
Age Group: Adult
Secondary Protocol No: 300726
Treatment: Device: iFuse 3-D in Bedrock Configuration Procedure: Multilevel Lumbar Fusion surgery
Therapies Involved: Surgery
ClinicalTrials.gov ID: NCT04062630
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Objective
To determine whether placement of iFuse-3D across the SIJ in the Bedrock configuration provides clinical and/or radiographic benefits in patients undergoing MLF surgery with fixation to the pelvis.
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Key Eligibility
Patient scheduled for multilevel (4 or more levels) spinal fusion
surgery with planned fixation to the pelvis using S2AI screws
