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Pelvic Fixation and Fusion During Multilevel Spinal Surgery

NCT05640908 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

  • Spinal Fusion
  • Deformity of Spine

Interventions

DEVICE

iFuse Bedrock Granite Implant System

Surgical procedure of the spine with pelvic fixation/fusion using iFuse Bedrock Granite

Sponsors & Collaborators

  • SI-BONE, Inc.

    lead INDUSTRY

Principal Investigators

  • Robyn Capobianco, PhD · SI-BONE, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-05
Primary Completion
2027-11-30
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05640908 on ClinicalTrials.gov