Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty
Terminated
- Conditions
- Knee Arthritis
- Registration Number
- NCT02831595
- Lead Sponsor
- Permedica spa
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 80
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline plasma metal ion concentrations (Co, Cr, Ni) at 12 months Preoperative and at 12 months follow-up
- Secondary Outcome Measures
Name Time Method Number of patients with metal sensitivity at 1 year tested by patch-testing 1 year follow-up