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Pelvic Fixation and Fusion During Multilevel Spinal Surgery

Study acronym: PAULA
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Nov 2026 to Nov 2027
    • Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Study completion date: Dec 2026 to Dec 2027
    v9
  2. Trial status: Recruiting to Enrolling by Invitation
    • Study sites: 8 to 9
    v8
  3. Study sites: 7 to 8v7
  4. Study sites: 6 to 7v6
  5. Study sites: 5 to 6v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 2 to 5v4
  2. Study sites: 1 to 2
    • Start date changed from estimate of May 2023 to Jun 5, 2023
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Dec 2022 to May 2023
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05640908
Lead Sponsor SI-BONE, Inc.
Conditions
(from sponsor)		 Spinal Fusion, Deformity of Spine
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov