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

This study is currently recruiting participants.
Verified May 2012 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
Additional Sponsor: Aesculap AG (Tuttlingen)
Information provided by (Responsible Party):
Georg Matziolis, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01601756
First received: May 14, 2012
Last updated: May 16, 2012
Last verified: May 2012
  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 Blind (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 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) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • indication for revision knee arthroplasty
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Georg Matziolis, Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01601756     History of Changes
Other Study ID Numbers: AAG-I-H-0917
Study First Received: May 14, 2012
Last Updated: May 16, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on April 17, 2014