NCT03047564

Brief Summary

Metal ion release from metal implants may have side effects. It can be reduced by coating of the implant. This study compares coated and uncoated TKA.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable knee-osteoarthritis

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 24, 2025

Status Verified

February 1, 2021

Enrollment Period

3.1 years

First QC Date

January 24, 2017

Last Update Submit

August 22, 2025

Conditions

Knee Osteoarthritis

Keywords

Total Knee ArthroplastyTotal Knee ReplacementOutcomeMetal ion concentrationResults

Outcome Measures

Primary Outcomes (1)

  • Metal Ions (Cobalt, Chromium, Molydenum, Nickel)

    Change in Serum Metal Ion concentrations 1 and 5 years after surgery

    before surgery, 1 year, 5 years

Secondary Outcomes (4)

  • Function

    before surgery, 3 month, 1 year, 5 years

  • Patient Reported Outcome

    before surgery, 3 month, 1 year, 5 years

  • Health-related Quality of Life

    before surgery, 3 month, 1 year, 5 years

  • Activity

    before surgery, 3 month, 1 year, 5 years

Other Outcomes (1)

  • Adverse Events

    through study completion, in average 5 years

Study Arms (2)

Coated Total Knee Arthroplasty

EXPERIMENTAL

Implantation of a coated Total Knee Arthroplasty

Device: Coated Total Knee Arthroplasty

Standard Total Knee Arthroplasty

ACTIVE COMPARATOR

Implantation of a Standard Total Knee Arthroplasty

Device: Standard Total Knee Arthroplasty

Interventions

Coated Total Knee ArthroplastyDEVICE

Implantation of a coated Total Knee Arthroplasty

Coated Total Knee Arthroplasty
Standard Total Knee ArthroplastyDEVICE

Implantation of a Standard Total Knee Arthroplasty

Standard Total Knee Arthroplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • indication to TKA
  • no other metal implant

You may not qualify if:

  • no informed consent
  • not able to understand study and/or questionnaires
  • Need of a higher constrained implant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jörg Lützner, MD

    University Hospital Carl Gustav Carus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomization to one of two implants
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2017

First Posted

February 9, 2017

Study Start

February 1, 2012

Primary Completion

February 28, 2015

Study Completion

December 1, 2020

Last Updated

August 24, 2025

Record last verified: 2021-02