Pelvic Fixation and Fusion During Multilevel Spinal Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pelvic Fixation and Fusion During Multilevel Spinal Surgery

Conditions
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Spinal Fusion, Deformity of Spine

Intervention / Treatment
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* Device: iFuse Bedrock Granite Implant System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective<br>Participants who have scheduled spinal fusion with pelvic fixation/fusion using iFuse Bedrock Granite. These participants will be followed for 2 years. | Device: iFuse Bedrock Granite Implant System<br>* Surgical procedure of the spine with pelvic fixation/fusion using iFuse Bedrock Granite<br>* Other names: Bedrock Granite;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: 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 | 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 |