Trials / Active Not Recruiting
Active Not RecruitingNCT05640908
Pelvic Fixation and Fusion During Multilevel Spinal Surgery
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- SI-BONE, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | iFuse Bedrock Granite Implant System | Surgical procedure of the spine with pelvic fixation/fusion using iFuse Bedrock Granite |
Timeline
- Start date
- 2023-06-05
- Primary completion
- 2027-11-01
- Completion
- 2027-12-01
- First posted
- 2022-12-07
- Last updated
- 2026-01-23
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05640908. Inclusion in this directory is not an endorsement.