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ACTIVE NOT RECRUITING
NCT05640908

Pelvic Fixation and Fusion During Multilevel Spinal Surgery

Sponsor: SI-BONE, Inc.

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.

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

Interventions

DEVICE

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