Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02831595|
Recruitment Status : Active, not recruiting
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
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.
|Condition or disease||Intervention/treatment|
|Knee Arthritis||Device: GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesis|
|Study Type :||Observational|
|Actual Enrollment :||80 participants|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||October 2018|
|Patients undergoing unilateral TKA||
Device: GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesis
- Change from baseline plasma metal ion concentrations (Co, Cr, Ni) at 12 months [ Time Frame: Preoperative and at 12 months follow-up ]
- Number of patients with metal sensitivity at 1 year tested by patch-testing [ Time Frame: 1 year follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831595
|Principal Investigator:||Nicola Ursino, MD||IRCCS Istituto Ortopedico Galeazzi Milano, Italy|