Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-04 @ 12:10 AM
Study NCT ID:
NCT03687593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-03
First Post:
2018-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Performance Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts
Sponsor:
Smith & Nephew, Inc.
Organization:
Study Overview
Official Title:
Safety and Performance of Primary Total Knee Arthroplasty Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts
Status:
ACTIVE_NOT_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:
Legion Oxinium
Brief Summary:
The purpose of this research is to collect data on patients that had the Legion CR Oxinium and CoCr Femoral Implant and the Legion/Genesis II XLPE High Flex Tibial Inserts implanted in the past. Smith \& Nephew will evaluate the safety and performance of these implants.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: