Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty
This trial is active, not recruiting.
|Treatment||gks prime flex bioloy by permedica, a tinbn coated fixed-bearing cruciate-retaining total knee prosthesis|
|Start date||June 2016|
|End date||October 2018|
|Trial size||80 participants|
|Trial identifier||NCT02831595, VCG-30-2015|
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.
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
Male or female participants from 18 years up to 80 years old.
Inclusion Criteria: - Patients candidate for unilateral primary total knee arthroplasty Exclusion Criteria: - Existing orthopaedic metal implants - A history of hypersensitivity to metals - Preoperative patch-test positivity to Co, Cr, Ni and Ti - Malignancies - Renal insufficiency - Severe illnesses that would impair participation in this study
|Principal investigator||Nicola Ursino, MD|
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