NCT00862511

Brief Summary

All metal implants release metal ions because of corrosion. Total knee arthroplasty implants have large metal surface areas and therefore substantial potential for corrosion. It is planned to compare changes in serum levels of metal ions in patients after implantation of cemented unconstrained total knee arthroplasty covered with or without a passivating surface. Serum concentrations of chromium, cobalt, molybdenum and nickel will be analyzed and compared between the two groups, as well as with those of 130 control patients without implants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

3.8 years

First QC Date

March 16, 2009

Last Update Submit

January 24, 2017

Conditions

OsteoarthritisMetal Ion Levels

Keywords

metal ion concentrationtotal knee arthroplastymetal hypersensitivity

Outcome Measures

Primary Outcomes (1)

  • Metal ion concentration in serum after TKA (Cr, Co, Mb, Ni)

    1 y and 5y

Secondary Outcomes (1)

  • Hypersensitivity against metal

    1 y

Study Arms (2)

Coated Total Knee Arthroplasty

EXPERIMENTAL

allergy coated TKA

Device: Coated Total Knee Arthroplasty

Standard Total Knee Arthroplasty

ACTIVE COMPARATOR

normal TKA

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

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for TKA in primary oder secondary osteoarthritis of the knee
  • Patient's consent

You may not qualify if:

  • Additional Implants present
  • Allergy against constituents of implant or cement
  • Any malignancies
  • Renal insufficiency
  • Any additional serious disease complicating the participation in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Dresden, Orthopaedic Department

Dresden, 01307, Germany

Location

Related Publications (2)

  • Lutzner J, Beyer F, Lutzner C, Thomas P, Summer B. Increased inflammatory response is associated with less favorable functional results 5 years after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2023 Apr;31(4):1316-1322. doi: 10.1007/s00167-021-06836-w. Epub 2022 Feb 11.

    PMID: 35147719DERIVED

  • Lutzner J, Dinnebier G, Hartmann A, Gunther KP, Kirschner S. Study rationale and protocol: prospective randomized comparison of metal ion concentrations in the patient's plasma after implantation of coated and uncoated total knee prostheses. BMC Musculoskelet Disord. 2009 Oct 14;10:128. doi: 10.1186/1471-2474-10-128.

    PMID: 19828019DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jörg Lützner, MD

    University Hospital Dresden, Orthopaedic Department

    PRINCIPAL INVESTIGATOR

  • Stephan Kirschner, MD

    University Hospital Dresden, Orthopaedic Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 17, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2012

Study Completion

January 1, 2017

Last Updated

January 25, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)