Clinical Trial

Pelvic Fixation and Fusion During Multilevel Spinal Surgery

Study acronym: PAULA
Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2022-11-28; most recent amendment 2026-01-21.
Status change: Enrolling by Invitation → Active, Not Recruiting 2026-01-21
Status change: Recruiting → Enrolling by Invitation 2025-05-08
Status change: Not Yet Recruiting → Recruiting 2023-05-05
Trial Details
NCT Number NCT05640908
Lead Sponsor SI-BONE, Inc.
Conditions Spinal Fusion, Deformity of Spine
Enrollment 200 participants
Start Date 2023-06-05
Primary Completion 2027-11 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-23