Pelvic Fixation and Fusion During Multilevel Spinal Surgery (PAULA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spinal Fusion; Deformity of Spine
• Intervention / Treatment: Device: iFuse Bedrock Granite Implant System

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36688
      • USA Neurosurgery
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado School of Medicine
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Corewell Health
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota
  • New York
    • Buffalo, New York, United States, 14203
      • University at Buffalo
    • New York, New York, United States, 10075
      • Northwell Health
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • Pinehurst Surgical Clinic
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health, Houston
    • Plano, Texas, United States, 75093
      • Texas Back Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with spinal fusion including pelvic fixation/fusion using GRANITE

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective; Participants who have scheduled spinal fusion with pelvic fixation/fusion using iFuse Bedrock Granite. These participants will be followed for 2 years.	Device: iFuse Bedrock Granite Implant System; Surgical procedure of the spine with pelvic fixation/fusion using iFuse Bedrock Granite; Other Names: GRANITE; Bedrock Granite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative incidence of serious adverse events probably or definitely related to GRANITE		2 years
Postoperative incidence of SI joint pain in subject without SI joint pain at baseline		2 years
Postoperative incidence of L5-S1 pseudoarthrosis		2 years
Postoperative incidence of pelvic construct failure	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	2 years
Postoperative incidence of device failures related to GRANITE (e.g., rod disengagement, screw pullout)		2 years
Radiographic	Bony apposition to the implant at 12 and 24 months as assessed by CT scan	12 month and 24 months
Change in Quality of Life PROs	Scores on PROs at follow up timepoints compared to baseline	6 month, 12 month and 24 months

Collaborators and Investigators

• Sponsor: SI-BONE, Inc.
• Investigators: Study Director: Robyn Capobianco, PhD, SI-BONE, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 301106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No