Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty

Permedica

Status: Terminated

Conditions: Knee Arthritis

Treatments: Device: GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesis

Study type: Observational

Funder types: Industry

Identifiers

NCT02831595

VCG-30-2015

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Patients undergoing unilateral TKA

Treatment:

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