Pelvic Fixation and Fusion During Multilevel Spinal Surgery

• Conditions: Spinal Fusion; Deformity of Spine
• Interventions: Device: iFuse Bedrock Granite Implant System

• Registration Number: NCT05640908
• Lead Sponsor: SI-BONE, Inc.

Brief 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.

Detailed Description

PAULA is a multicenter, open label, single-arm observational clinical study consisting of prospective and retrospective study cohorts. The goal of the study is to collect data on the safety, performance, and effectiveness of GRANITE.

Study Timeline

• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-11-28
• Study First Posted: 2022-12-07
• Study Start: 2023-06-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-11
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. ≥ 18 years of age at screening.
2. Patient is scheduled for spinal fusion with pelvic fixation/fusion using iFuse Bedrock Granite
3. Patient is willing and able to provide written informed consent

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective	iFuse Bedrock Granite Implant System	Participants who have scheduled spinal fusion with pelvic fixation/fusion using iFuse Bedrock Granite. These participants will be followed for 2 years.

Primary Outcome Measures

Name	Time	Method
Postoperative incidence of SI joint pain in subject without SI joint pain at baseline	2 years
Postoperative incidence of serious adverse events probably or definitely related to GRANITE	2 years
Radiographic	12 month and 24 months	Bony apposition to the implant at 12 and 24 months as assessed by CT scan
Postoperative incidence of device failures related to GRANITE (e.g., rod disengagement, screw pullout)	2 years
Postoperative incidence of L5-S1 pseudoarthrosis	2 years
Change in Quality of Life PROs	6 month, 12 month and 24 months	Scores on PROs at follow up timepoints compared to baseline
Postoperative incidence of pelvic construct failure	2 years	Failure is defined as: * Breakage of any implants placed into sacrum or ilium; * Rod breakage in the lumbosacral region; * Pelvic implant loosening that either causes new or worsened pain or requires surgical adjustment/revision

Trial Locations

Locations (9)

University of Texas Health, Houston; 🇺🇸 Houston, Texas, United States

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

Texas Back Institute; 🇺🇸 Plano, Texas, United States