Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty

Knee Arthritis Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02831595
• Other study ID #: VCG-30-2015
• Status: Terminated
• Start date: June 2016
• Est. completion date: January 2019

Study information

• Verified date: October 2019
• Source: Permedica spa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Knee Arthritis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Permedica spa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline plasma metal ion concentrations (Co, Cr, Ni) at 12 months		Preoperative and at 12 months follow-up
Secondary	Number of patients with metal sensitivity at 1 year tested by patch-testing		1 year follow-up