NCT05640908

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jun 2023

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Jun 2023Dec 2027

First Submitted

Initial submission to the registry

November 28, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

June 5, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

4.4 years

First QC Date

November 28, 2022

Last Update Submit

January 21, 2026

Conditions

Spinal FusionDeformity of Spine

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (1)

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

Interventions

iFuse Bedrock Granite Implant SystemDEVICE

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

Also known as: GRANITE, Bedrock Granite
Prospective

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with spinal fusion including pelvic fixation/fusion using GRANITE

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

USA Neurosurgery

Mobile, Alabama, 36688, United States

Location

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Corewell Health

Royal Oak, Michigan, 48073, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

University at Buffalo

Buffalo, New York, 14203, United States

Location

Northwell Health

New York, New York, 10075, United States

Location

Pinehurst Surgical Clinic

Pinehurst, North Carolina, 28374, United States

Location

University of Texas Health, Houston

Houston, Texas, 77030, United States

Location

Texas Back Institute

Plano, Texas, 75093, United States

Location

Study Officials

  • Robyn Capobianco, PhD

    SI-BONE, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2022

First Posted

December 7, 2022

Study Start

June 5, 2023

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(9)