Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Knee Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing unilateral TKA

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

Intervention Type DEVICE

Interventions

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No