Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:26 PM
Study NCT ID:
NCT04118894
Status:
TERMINATED
Last Update Posted:
2025-01-14
First Post:
2019-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Wright Foot & Ankle Post-Market Observational Study
Sponsor:
Stryker Trauma and Extremities
Organization:
Study Overview
Official Title:
Wright Foot & Ankle Post-Market Observational Study
Status:
TERMINATED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to COVID the enrollment into the study was delayed. Sponsor chose to collect clinical data via alternative methods.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
WRIGHT FOOT \& ANKLE POST-MARKET OBSERVATIONAL STUDY, Multi-Year, Multi-Site, Multi-Device, Post-Market Observational Study, 10 sites, a minimum of 40 patients per device
Detailed Description:
The selected design is a global, multi-center, non-randomized, prospective observational study. The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.
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?: