Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
SI-BONE, Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Pelvic Fixation and Fusion During Multilevel Spinal Surgery
