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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05640908
Other study ID # 301106
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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