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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective | Participants who have scheduled spinal fusion with pelvic fixation/fusion using iFuse Bedrock Granite. These participants will be followed for 2 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iFuse Bedrock Granite Implant System | Device | Surgical procedure of the spine with pelvic fixation/fusion using iFuse Bedrock Granite |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Failure is defined as:
| 2 years |
| Postoperative incidence of device failures related to GRANITE (e.g., rod disengagement, screw pullout) | 2 years | |
| Radiographic | Bony apposition to the implant at 12 and 24 months as assessed by CT scan | 12 month and 24 months |
| Change in Quality of Life PROs | Scores on PROs at follow up timepoints compared to baseline | 6 month, 12 month and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with spinal fusion including pelvic fixation/fusion using GRANITE
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| Name | Affiliation | Role |
|---|---|---|
| Robyn Capobianco, PhD | SI-BONE, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA Neurosurgery | Mobile | Alabama | 36688 | United States | ||
| University of Colorado School of Medicine |
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| Aurora |
| Colorado |
| 80045 |
| United States |
| Corewell Health | Royal Oak | Michigan | 48073 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55454 | United States |
| University at Buffalo | Buffalo | New York | 14203 | United States |
| Northwell Health | New York | New York | 10075 | United States |
| Pinehurst Surgical Clinic | Pinehurst | North Carolina | 28374 | United States |
| University of Texas Health, Houston | Houston | Texas | 77030 | United States |
| Texas Back Institute | Plano | Texas | 75093 | United States |