Pelvic Fixation and Fusion During Multilevel Spinal Surgery

Running, not enrolling

Conditions studied: Spinal Fusion, Deformity of Spine

In brief

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 facts

Study ID

NCT05640908

Run by

SI-BONE, Inc.

People needed

200

Starts

2023-06-05

Expected to finish

2027-12-01

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age at screening.
• Patient is scheduled for spinal fusion with pelvic fixation/fusion using iFuse Bedrock Granite
• Patient is willing and able to provide written informed consent

You may not qualify if…

• Any known anatomic issues or permanent implants already in the pelvis that could interfere with placement of the study device(s)
• Prominent neurologic or uncontrolled psychiatric condition that would interfere with study participation
• Known allergy to titanium or titanium alloys
• Current local or systemic infection that raises the risk of surgery
• Currently pregnant or planning pregnancy in the next 2 years
• Known or suspected active drug or alcohol abuse, including opioids
• Patient is a prisoner or ward of the state
• Patient is enrolled in an investigational clinical trial related to the spine

Where it is running

• 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

Full record on ClinicalTrials.gov

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