Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02831595

Enrollment

Registered

2016-07-13

Start date

2016-06-30

Completion date

2019-01-31

Last updated

2019-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthritis

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.

Interventions

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026