Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2026-02-13 @ 11:50 AM
Study NCT ID:
NCT02831595
Status:
TERMINATED
Last Update Posted:
2019-10-23
First Post:
2016-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty
Sponsor:
Permedica spa
Organization:
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment stopped for missing availability of the site
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Modern knee implants combine several types of metal and therefore potentially expose patients to different metal ions.
Titanium niobium nitride coating (TiNbN) acts like a physical barrier against the corrosion process and the metallic ions release towards the surrounding biologic environment, thus, making TiNbN-coated prostheses possible to be safety implanted in metal sensitized patients.
The aim of the study is to verify that the postoperative plasma metal concentrations at 1 year are not different than preoperative values.
Titanium niobium nitride coating (TiNbN) acts like a physical barrier against the corrosion process and the metallic ions release towards the surrounding biologic environment, thus, making TiNbN-coated prostheses possible to be safety implanted in metal sensitized patients.
The aim of the study is to verify that the postoperative plasma metal concentrations at 1 year are not different than preoperative values.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: