Pelvic Fixation and Fusion During Multilevel Spinal Surgery

Launched by SI-BONE, INC. · Nov 28, 2022

Keywords

ClinConnect Summary

This clinical trial, called PAULA, is studying a new device called iFuse Bedrock Granite, which is used during spinal fusion surgery that also involves fixing the pelvis. The goal is to gather information about how safe and effective this device is for patients undergoing this type of surgery, specifically for those with spinal deformities. The trial is currently looking for participants aged 18 and older who are scheduled for this surgery and are willing to give their consent to take part in the study.

To be eligible, participants should not have any existing problems in their pelvis that could affect the surgery, and they should not have certain medical conditions that could interfere with their participation. Additionally, those with allergies to titanium, current infections, or those who are pregnant or planning to become pregnant in the next two years cannot participate. If someone meets the eligibility criteria and decides to join, they can expect to be part of an important study that could help improve spinal surgery outcomes for future patients.

Gender

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Eligibility criteria

• 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

Trial Officials