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Active, Not Recruiting

NCT Number: NCT05640908

Pelvic Fixation and Fusion During Multilevel Spinal Surgery

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Spinal Fusion Deformity of Spine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

USA Neurosurgery, Mobile, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 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

Exclusion criteria

  • 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

Treatment and study plan

iFuse Bedrock Granite Implant System

Device

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

Other names: GRANITE, Bedrock Granite

Primary outcomes

  1. Postoperative incidence of serious adverse events probably or definitely related to GRANITE

    Time frame: 2 years

  2. Postoperative incidence of SI joint pain in subject without SI joint pain at baseline

    Time frame: 2 years

  3. Postoperative incidence of L5-S1 pseudoarthrosis

    Time frame: 2 years

  4. Postoperative incidence of pelvic construct failure

    Time frame: 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

  5. Postoperative incidence of device failures related to GRANITE (e.g., rod disengagement, screw pullout)

    Time frame: 2 years

  6. Radiographic

    Time frame: 12 month and 24 months

    Bony apposition to the implant at 12 and 24 months as assessed by CT scan

  7. Change in Quality of Life PROs

    Time frame: 6 month, 12 month and 24 months

    Scores on PROs at follow up timepoints compared to baseline

Sponsors and collaborators

Lead sponsor

SI-BONE, Inc.

Industry

Registry information

Acronym: PAULA

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 7, 2022
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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