Deformity of Spine, Spinal Fusion
Conditions
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.
Interventions
DEVICEiFuse Bedrock Granite Implant System
Surgical procedure of the spine with pelvic fixation/fusion using iFuse Bedrock Granite
Sponsors
SI-BONE, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
STUDY_DIRECTORRobyn Capobianco, PhD
SI-BONE, Inc.
Outcome results
None listed