Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2026-01-01 @ 5:25 AM
Study NCT ID:
NCT05364606
Status:
RECRUITING
Last Update Posted:
2024-11-07
First Post:
2022-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Specific Talus Spacer Post Approval Study
Sponsor:
Paragon 28
Organization:
Study Overview
Official Title:
Patient Specific Talus Spacer Post Approval Study
Status:
RECRUITING
Status Verified Date:
2024-11
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:
Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.
Detailed Description:
This is a Humanitarian Device Exemption (HDE) approved device called the Patient Specific Talus Spacer. This is a post approval study to determine the safety and probable benefit of the Patient Specific Talus Spacer in commercial use. The Patient Specific Talus Spacer is a solid polished replica of the patient's bone to allow the patient to regain motion and reduce pain.
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?:
False
Is an FDA AA801 Violation?: