Ignite Creation Date:
2024-05-05 @ 11:14 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01284283
Status:
COMPLETED
Last Update Posted:
2022-07-29
First Post:
2010-11-02
Brief Title:
2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System STAR Ankle Under Actual Conditions of Use
Sponsor:
Encore Medical LP
Organization:
Encore Medical LP
Study Overview
Official Title:
2-Year Post-Approval Study to Investigate the STAR Ankle Under Actual Conditions of Use
Status:
COMPLETED
Status Verified Date:
2022-07
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:
STAR 2 PAS
Brief Summary:
This post-approval study is being conducted to examine the performance of the STAR Ankle under actual conditions of use
Detailed Description:
This investigation is a prospective multi-center single-arm study 98 subjects are to be enrolled in this clinical investigation Enrolled subjects will be assessed at Pre-Operative OperativeDischarge and at 6 Weeks 6 12 and 24 Months after the index procedure Safety efficacy and effectiveness analyses will be performed for all follow-up points during the study
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?:
None
Is an FDA AA801 Violation?:
None