Pelvic Fixation and Fusion During Multilevel Spinal Surgery

N/AActive Not RecruitingNCT05640908

SI-BONE, Inc.200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Spinal Fusion Deformity of Spine

Interventions

iFuse Bedrock Granite Implant SystemDEVICE

Surgical procedure of the spine with pelvic fixation/fusion using iFuse Bedrock Granite

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

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

Outcomes

Primary Outcomes

Postoperative incidence of serious adverse events probably or definitely related to GRANITE

Time frame: 2 years

Postoperative incidence of SI joint pain in subject without SI joint pain at baseline

Time frame: 2 years

Postoperative incidence of L5-S1 pseudoarthrosis

Time frame: 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

Time frame: 2 years

Postoperative incidence of device failures related to GRANITE (e.g., rod disengagement, screw pullout)

Time frame: 2 years

Radiographic

Bony apposition to the implant at 12 and 24 months as assessed by CT scan

Time frame: 12 month and 24 months

Change in Quality of Life PROs

Scores on PROs at follow up timepoints compared to baseline

Time frame: 6 month, 12 month and 24 months

Data from ClinicalTrials.gov

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