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Pelvic Fixation and Fusion During Multilevel Spinal Surgery
Sponsor: SI-BONE, Inc.
Summary
PAULA aims to collect data on the safety, performance, and effectiveness of iFuse Bedrock Granite (GRANITE) in patients who have spinal fusion surgery with pelvic fixation/ fusion.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2023-06-05
Completion Date
2027-12
Last Updated
2026-01-23
Healthy Volunteers
No
Conditions
Interventions
iFuse Bedrock Granite Implant System
Surgical procedure of the spine with pelvic fixation/fusion using iFuse Bedrock Granite
Locations (9)
USA Neurosurgery
Mobile, Alabama, United States
University of Colorado School of Medicine
Aurora, Colorado, United States
Corewell Health
Royal Oak, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
University at Buffalo
Buffalo, New York, United States
Northwell Health
New York, New York, United States
Pinehurst Surgical Clinic
Pinehurst, North Carolina, United States
University of Texas Health, Houston
Houston, Texas, United States
Texas Back Institute
Plano, Texas, United States