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Joint Line Reconstruction in Navigated Total Knee Arthroplasty Revision (NavRevKnie)

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ClinicalTrials.gov Identifier: NCT01601756
Recruitment Status : Unknown
Verified May 2012 by Georg Matziolis, Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : May 18, 2012
Last Update Posted : May 18, 2012
Sponsor:
Collaborator:
Additional Sponsor: Aesculap AG (Tuttlingen)
Information provided by (Responsible Party):
Georg Matziolis, Charite University, Berlin, Germany

Brief Summary:
Hypothesis: navigated revision total knee arthroplasty results in a more precise reconstruction of preoperatively planned joint line than conventional revision total knee arthroplasty (rTKA).

Condition or disease Intervention/treatment Phase
Revision Total Knee Arthroplasty Because of Loosening Instability Impingement or Other Reasons Accepted as Indications for TKA Exchange. The Focus is to Determine the Precision of Joint Line Restoration in Navigated vs. Conventional Revision Total Knee Arthroplasty Device: navigated revision knee arthroplasty Device: conventional revision knee arthroplasty Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Joint Line Reconstruction in Navigated Total Knee Arthroplasty Revision
Study Start Date : September 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: navigated revision total knee arthroplasty
revision total knee arthroplasty with the aid of a navigation system
Device: navigated revision knee arthroplasty
revision knee arthroplasty with the aid of a navigation system the navigation system is the Orthopilot System with a software specifically dedicated for revision operations (TKR 1.0). The system is from Aesculap AG (Tuttlingen).
Active Comparator: conventional revision knee arthroplasty
revision knee arthroplasty using conventional instruments
Device: conventional revision knee arthroplasty
revision knee arthroplasty using conventional instruments



Primary Outcome Measures :
  1. Restoration of Joint Line [ Time Frame: postoperatively (6 to 12 weeks after operation, we expect a mean of 9 weeks) ]
    Difference between preoperatively planned and postoperatively achieved joint line



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • indication for revision knee arthroplasty

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601756


Contacts
Contact: Georg Matziolis, MD +49 30 450 615093 georg.matziolis@charite.de

Locations
Germany
Orthopaedic Department, Charité - University Medicine Berlin Recruiting
Berlin, Germany, 10117
Contact: Georg Matziolis, MD    +49 30 450 615093    georg.matziolis@charite.de   
Principal Investigator: Georg Matziolis, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Additional Sponsor: Aesculap AG (Tuttlingen)

Responsible Party: Georg Matziolis, Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01601756     History of Changes
Other Study ID Numbers: AAG-I-H-0917
First Posted: May 18, 2012    Key Record Dates
Last Update Posted: May 18, 2012
Last Verified: May 2012

Keywords provided by Georg Matziolis, Charite University, Berlin, Germany:
revision knee arthroplasty
navigation
joint line