NCT02831595

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

2.6 years

First QC Date

June 29, 2016

Last Update Submit

October 21, 2019

Conditions

Knee Arthritis

Outcome Measures

Primary Outcomes (1)

  • Change from baseline plasma metal ion concentrations (Co, Cr, Ni) at 12 months

    Preoperative and at 12 months follow-up

Secondary Outcomes (1)

  • Number of patients with metal sensitivity at 1 year tested by patch-testing

    1 year follow-up

Study Arms (1)

Patients undergoing unilateral TKA

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

Interventions

GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesisDEVICE
Patients undergoing unilateral TKA

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a diagnosis of knee osteoarthritis scheduled for unilateral TKA

You may qualify if:

  • Patients candidate for unilateral primary total knee arthroplasty

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Nicola Ursino, MD

    IRCCS Istituto Ortopedico Galeazzi Milano, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 13, 2016

Study Start

June 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

October 23, 2019

Record last verified: 2019-10