Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty

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 Overview

• Status: Terminated
• Conditions: Knee Arthritis
• Intervention / Treatment: Device: GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesis

• Study Type: Observational
• Enrollment (Actual): 80

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of knee osteoarthritis scheduled for unilateral TKA

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing unilateral TKA	Device: GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline plasma metal ion concentrations (Co, Cr, Ni) at 12 months	Preoperative and at 12 months follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with metal sensitivity at 1 year tested by patch-testing	1 year follow-up

Collaborators and Investigators

• Sponsor: Permedica spa
• Investigators: Principal Investigator: Nicola Ursino, MD, IRCCS Istituto Ortopedico Galeazzi Milano, Italy

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: June 29, 2016
• First Submitted That Met QC Criteria: July 8, 2016
• First Posted (Estimate): July 13, 2016

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: VCG-30-2015