Pelvic Fixation and Fusion During Multilevel Spinal Surgery (PAULA)

SI-Bone

Status: Enrolling

Conditions: Deformity of Spine; Spinal Fusion

Treatments: Device: iFuse Bedrock Granite Implant System

Study type: Observational

Funder types: Industry

Identifiers

NCT05640908

301106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Prospective

Description:

Participants who have scheduled spinal fusion with pelvic fixation/fusion using iFuse Bedrock Granite. These participants will be followed for 2 years.

Treatment:

Device: iFuse Bedrock Granite Implant System