Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-31 @ 12:53 PM
Study NCT ID:
NCT03060057
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-05
First Post:
2017-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study"
Sponsor:
United Orthopedic Corporation
Organization:
Study Overview
Official Title:
Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study"
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
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:
U-Propel
Brief Summary:
The purpose of this study is to evaluate both short and long term clinical performance and safety of the commercially available U2 Knee™ System.
Detailed Description:
This is a prospective, single arm, multi-center, post-approval study designed to evaluate the short and long term clinical performance and safety in subjects receiving primary total knee arthroplasty (TKA) with the U2 Knee™ System. The study will enroll up to 200 subjects with scheduled pre-discharge, 6-week, 3- and 6-month and up to 5-year annual follow-up visits. Study outcomes will be analyzed and published when 1.) all enrolled and implanted subjects complete their 6-week follow up, 2.) all implanted subjects complete their 2-year follow up, 3.) at the conclusion of the study.
The study will follow GCP guidelines and will be registered on clinicaltrials.gov.
The study will follow GCP guidelines and will be registered on clinicaltrials.gov.
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?: