Pelvic Fixation and Fusion During Multilevel Spinal Surgery
- Conditions
- Spinal FusionDeformity of Spine
- Registration Number
- NCT05640908
- Lead Sponsor
- SI-BONE, Inc.
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 200
- ≥ 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative incidence of SI joint pain in subject without SI joint pain at baseline 2 years Postoperative incidence of serious adverse events probably or definitely related to GRANITE 2 years Postoperative incidence of device failures related to GRANITE (e.g., rod disengagement, screw pullout) 2 years Postoperative incidence of L5-S1 pseudoarthrosis 2 years Change in Quality of Life PROs 6 month, 12 month and 24 months Scores on PROs at follow up timepoints compared to baseline
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/revisionRadiographic 12 month and 24 months Bony apposition to the implant at 12 and 24 months as assessed by CT scan
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
University of Texas Health, Houston
🇺🇸Houston, Texas, United States
USA Neurosurgery
🇺🇸Mobile, Alabama, United States
University of Colorado School of Medicine
🇺🇸Aurora, Colorado, United States
Corewell Health
🇺🇸Royal Oak, Michigan, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University at Buffalo
🇺🇸Buffalo, New York, United States
Northwell Health
🇺🇸New York, New York, United States
Pinehurst Surgical Clinic
🇺🇸Pinehurst, North Carolina, United States
Texas Back Institute
🇺🇸Plano, Texas, United States
University of Texas Health, Houston🇺🇸Houston, Texas, United States