Effectiveness of Titanium Niobium Nitride Coating in Tota... | NCT02831595

Studies
Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty

NCT02831595

Sponsor

Permedica spa

Status

Terminated

Last Update Posted

Oct 23, 2019Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Knee Arthritis

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrollment stopped for missing availability of the site

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Jan 2019Actual

Completion Date

Jan 2019Actual

First Submitted Date

Jun 29, 2016

First Submission Date that Met QC Criteria

Jul 8, 2016

First Posted Date

Jul 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2019

Last Update Posted Date

Oct 23, 2019Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients undergoing unilateral TKA			Device: GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesis	Device		Patients undergoing unilateral TKA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline plasma metal ion concentrations (Co, Cr, Ni) at 12 months		Preoperative and at 12 months follow-up

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with metal sensitivity at 1 year tested by patch-testing		1 year follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with a diagnosis of knee osteoarthritis scheduled for unilateral TKA

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicola Ursino, MD	IRCCS Istituto Ortopedico Galeazzi Milano, Italy	Principal Investigator

Locations

Not provided