Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty

Permedica spa80 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Knee Arthritis

Interventions

GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesisDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline plasma metal ion concentrations (Co, Cr, Ni) at 12 months

Time frame: Preoperative and at 12 months follow-up

Secondary Outcomes

Number of patients with metal sensitivity at 1 year tested by patch-testing

Time frame: 1 year follow-up

Data from ClinicalTrials.gov

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