Pelvic Fixation and Fusion During Multilevel Spinal Surgery

Spinal Fusion Clinical Trial

— PAULA  

Official title:

Pelvic Fixation and Fusion During Multilevel Spinal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05640908
• Other study ID #: 301106
• Status: Recruiting
• Start date: June 5, 2023
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: SI-BONE, Inc.
• Contact: Robyn Capobianco, PhD
• Phone: 408-207-0700
• Email: robyn.capobianco[@]si-bone.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Deformity of Spine
• Spinal Fusion

Intervention

Device:
• iFuse Bedrock Granite Implant System
Surgical procedure of the spine with pelvic fixation/fusion using iFuse Bedrock Granite

Locations

Country	Name	City	State
United States	University of Colorado School of Medicine	Aurora	Colorado
United States	University at Buffalo	Buffalo	New York
United States	University of Minnesota	Minneapolis	Minnesota
United States	USA Neurosurgery	Mobile	Alabama
United States	Northwell Health	New York	New York
United States	Pinehurst Surgical Clinic	Pinehurst	North Carolina
United States	Texas Back Institute	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
SI-BONE, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative incidence of serious adverse events probably or definitely related to GRANITE		2 years
Primary	Postoperative incidence of SI joint pain in subject without SI joint pain at baseline		2 years
Primary	Postoperative incidence of L5-S1 pseudoarthrosis		2 years
Primary	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
Primary	Postoperative incidence of device failures related to GRANITE (e.g., rod disengagement, screw pullout)		2 years
Primary	Radiographic	Bony apposition to the implant at 12 and 24 months as assessed by CT scan	12 month and 24 months
Primary	Change in Quality of Life PROs	Scores on PROs at follow up timepoints compared to baseline	6 month, 12 month and 24 months