Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657248
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-23
Brief Title:
Clinical Performance and Safety of the Unicompartmental Univation XF Pro Implant
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Multicenter Study Evaluating the Midterm Clinical Performance and Safety of the Unicompartmental Univation XF Pro Knee Implant
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UNI XF PRO
Brief Summary:
The study is designed as a prospective observational mid-term multi-center follow-up study It is planned to include 150 patients from 4 different study centres in Germany The product under investigation is used in routine clinical practice and according to the authorized Instructions for Use IfU The data that is obtained in routine clinical use will be documented in an electronical Case Report Form eCRF The studys main purpose is the collection of clinical data on the safety and performance of the redesigned univation XF Pro implant
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None