Pelvic Fixation and Fusion During Multilevel Spinal Surgery

Last updated: November 19, 2024
Sponsor: SI-BONE, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Holoprosencephaly

Spine Athroplasty

Birth Defects

Treatment

iFuse Bedrock Granite Implant System

Clinical Study ID

NCT05640908
301106
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥ 18 years of age at screening.

  2. Patient is scheduled for spinal fusion with pelvic fixation/fusion using iFuseBedrock Granite

  3. Patient is willing and able to provide written informed consent

Exclusion

Exclusion Criteria:

  1. Any known anatomic issues or permanent implants already in the pelvis that couldinterfere with placement of the study device(s)

  2. Prominent neurologic or uncontrolled psychiatric condition that would interfere withstudy 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

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: iFuse Bedrock Granite Implant System
Phase:
Study Start date:
June 05, 2023
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • USA Neurosurgery

    Mobile, Alabama 36688
    United States

    Active - Recruiting

  • University of Colorado School of Medicine

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Corewell Health

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55454
    United States

    Active - Recruiting

  • University at Buffalo

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • Northwell Health

    New York, New York 10075
    United States

    Active - Recruiting

  • Pinehurst Surgical Clinic

    Pinehurst, North Carolina 28374
    United States

    Active - Recruiting

  • Texas Back Institute

    Plano, Texas 75093
    United States

    Active - Recruiting

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