Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
Study NCT ID:
NCT05179005
Status:
TERMINATED
Last Update Posted:
2024-01-29
First Post:
2021-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RibFix Advantage™ Post-Market Follow-Up
Sponsor:
Zimmer Biomet
Organization:
Study Overview
Official Title:
Zimmer Biomet Patient Outcome and Experience After Chest Wall Repair With RibFix Advantage™
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZB-PIONEER
Brief Summary:
To confirm safety, performance, and clinical benefits for the use of RibFix Advantage™ in the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone
Detailed Description:
Retrospective review of subject demographic and hospital data with a prospective follow-up component evaluating clinical outcomes and quality of life for patients receiving RibFix Advantage for surgical stabilization of rib fractures from 2019 to 2021
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: