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Application of Computer-assisted Navigation in Total Knee Arthroplasty: A Randomized Pair-matched Double-blind Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00982956
First Posted: September 23, 2009
Last Update Posted: September 23, 2009
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.
Information provided by:
Chinese PLA General Hospital
  Purpose

Objective:

The purpose of this study is to evaluate the application of computer-assisted navigation in Total Knee Arthroplasty (TKA ) by comparing it with conventional TKA.

Methods:

Gemini MK II implants (Link, Germany) were used. VectorVisionâ CT-free navigation system (BrainLab, Germany) was employed for the TKA. For each subject, computer-navigation TKA and the conventional TKA were separately performed on two knee joints. The operative method and order of the operations were decided on a randomized basis. All the patients and doctors conducting follow-up study and performing imaging measurement were blind to selection of the operation. Student t test was used for statistical analysis.

hypothesis: computer-assisted navigation system can significantly improve the accuracy of tibial and femoral cuts on coronal and sagittal planes.


Condition
Knee Arthritis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Further study details as provided by Chinese PLA General Hospital:

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
the subjects who had been scheduled for simultaneous bilateral TKA,
Criteria

Inclusion Criteria:

  • plan for simultaneous bilateral TKA.

Exclusion Criteria:

  • plan for unilateral TKA.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00982956     History of Changes
Other Study ID Numbers: 2007023
First Submitted: September 22, 2009
First Posted: September 23, 2009
Last Update Posted: September 23, 2009
Last Verified: September 2009