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

May 16, 2012 updated by: Georg Matziolis, Charite University, Berlin, Germany
Hypothesis: navigated revision total knee arthroplasty results in a more precise reconstruction of preoperatively planned joint line than conventional revision total knee arthroplasty (rTKA).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Orthopaedic Department, Charité - University Medicine Berlin
        • Contact:
        • Principal Investigator:
          • Georg Matziolis, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • indication for revision knee arthroplasty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
postoperatively (6 to 12 weeks after operation, we expect a mean of 9 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Aesculap AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

May 14, 2012

First Submitted That Met QC Criteria

May 16, 2012

First Posted (ESTIMATE)

May 18, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 18, 2012

Last Update Submitted That Met QC Criteria

May 16, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AAG-I-H-0917

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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