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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Georg Matziolis, Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01601756
First Posted: May 18, 2012
Last Update Posted: May 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Additional Sponsor: Aesculap AG (Tuttlingen)
Information provided by (Responsible Party):
Georg Matziolis, Charite University, Berlin, Germany
  Purpose
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 Intervention
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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Georg Matziolis, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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)
  More Information

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 Submitted: May 14, 2012
First Posted: May 18, 2012
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