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Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty

NCT02831595 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2019-10-23

No results posted yet for this study

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.

Conditions

  • Knee Arthritis

Interventions

DEVICE

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

Sponsors & Collaborators

  • Permedica spa

    lead INDUSTRY

Principal Investigators

  • Nicola Ursino, MD · IRCCS Istituto Ortopedico Galeazzi Milano, Italy

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-01-31
Completion
2019-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02831595 on ClinicalTrials.gov