๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-01-21

Pelvic Fixation and Fusion During Multilevel Spinal Surgery (NCT05640908)

๐Ÿ”ต Active, Not Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: SI-BONE, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: USA Neurosurgery โ€” Mobile, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (9 Sites)

  • USA Neurosurgery โ€” Mobile, Alabama
  • University of Colorado School of Medicine โ€” Aurora, Colorado
  • Corewell Health โ€” Royal Oak, Michigan
  • University of Minnesota โ€” Minneapolis, Minnesota
  • University at Buffalo โ€” Buffalo, New York
  • Northwell Health โ€” New York, New York
  • Pinehurst Surgical Clinic โ€” Pinehurst, North Carolina
  • University of Texas Health, Houston โ€” Houston, Texas
  • Texas Back Institute โ€” Plano, Texas

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Spinal Fusion clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—