Overview

This trial is active, not recruiting.

Condition knee arthritis
Treatment gks prime flex bioloy by permedica, a tinbn coated fixed-bearing cruciate-retaining total knee prosthesis
Sponsor Permedica Manufacturing
Start date June 2016
End date October 2018
Trial size 80 participants
Trial identifier NCT02831595, VCG-30-2015

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
gks prime flex bioloy by permedica, a tinbn coated fixed-bearing cruciate-retaining total knee prosthesis

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Principal investigator Nicola Ursino, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Permedica Manufacturing.