Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-01 @ 10:21 PM
Study NCT ID:
NCT05190159
Status:
COMPLETED
Last Update Posted:
2022-09-23
First Post:
2021-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monster Screw System Post-Market Clinical Follow-Up Study
Sponsor:
Paragon 28
Organization:
Study Overview
Official Title:
Monster Screw System Post-Market Clinical Follow-Up Study
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Post-market clinical follow-up study on the Monster Screw System
Detailed Description:
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Monster Screw System.
Study Oversight
Has Oversight DMC:
None
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?: