Clinical Trials in the USA / NCT05640908
Active, not recruiting
Observational
Pelvic Fixation and Fusion During Multilevel Spinal Surgery
NCT05640908 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Spinal FusionDeformity of Spine
Investigational drug(s) / intervention(s)
iFuse Bedrock Granite Implant System
iFuse Bedrock Granite Implant System: Surgical procedure of the spine with pelvic fixation/fusion using iFuse Bedrock Granite
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
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
Primary outcome measure(s)
- 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 — 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 - Postoperative incidence of device failures related to GRANITE (e.g., rod disengagement, screw pullout) — 2 years
- Radiographic — 12 month and 24 months
Bony apposition to the implant at 12 and 24 months as assessed by CT scan - Change in Quality of Life PROs — 6 month, 12 month and 24 months
Scores on PROs at follow up timepoints compared to baseline
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| USA Neurosurgery | Mobile | Alabama | |
| University of Colorado School of Medicine | Aurora | Colorado | |
| Corewell Health | Royal Oak | Michigan | |
| University of Minnesota | Minneapolis | Minnesota | |
| University at Buffalo | Buffalo | New York | |
| Northwell Health | New York | New York | |
| Pinehurst Surgical Clinic | Pinehurst | North Carolina | |
| University of Texas Health, Houston | Houston | Texas | |
| Texas Back Institute | Plano | Texas |
More SI-BONE, Inc. trials in the USA
Innovative Spinopelvic Solutions With Real-World Evidence
Active, not recruiting
iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction
Active, not recruiting
Other trials for the same condition
Artoss Prospective Spine Registry Outcomes
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05640908 on ClinicalTrials.gov ↗ ← All trials in the USA