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Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02831595
Recruitment Status : Terminated (Enrollment stopped for missing availability of the site)
First Posted : July 13, 2016
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Permedica spa

Study Description
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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.


Condition or disease Intervention/treatment
Knee Arthritis Device: GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesis

Study Design
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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : June 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline plasma metal ion concentrations (Co, Cr, Ni) at 12 months [ Time Frame: Preoperative and at 12 months follow-up ]

Secondary Outcome Measures :
  1. Number of patients with metal sensitivity at 1 year tested by patch-testing [ Time Frame: 1 year follow-up ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of knee osteoarthritis scheduled for unilateral TKA
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831595


Sponsors and Collaborators
Permedica spa
Investigators
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Principal Investigator: Nicola Ursino, MD IRCCS Istituto Ortopedico Galeazzi Milano, Italy
More Information
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Responsible Party: Permedica spa
ClinicalTrials.gov Identifier: NCT02831595    
Other Study ID Numbers: VCG-30-2015
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases