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

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. Identifier: NCT00982956
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : September 23, 2009
Information provided by:
Chinese PLA General Hospital

Brief Summary:


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.


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 or disease
Knee Arthritis

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

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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,

Inclusion Criteria:

  • plan for simultaneous bilateral TKA.

Exclusion Criteria:

  • plan for unilateral TKA. Identifier: NCT00982956     History of Changes
Other Study ID Numbers: 2007023
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: September 23, 2009
Last Verified: September 2009