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

This study has been completed.
Sponsor:
Information provided by:
Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT00982956
First received: September 22, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted

September 22, 2009
September 22, 2009
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Application of Computer-assisted Navigation in Total Knee Arthroplasty: A Randomized Pair-matched Double-blind Trial
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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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

the subjects who had been scheduled for simultaneous bilateral TKA,

Knee Arthritis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

  • plan for simultaneous bilateral TKA.

Exclusion Criteria:

  • plan for unilateral TKA.
Both
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Contact information is only displayed when the study is recruiting subjects
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NCT00982956
2007023
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Chinese PLA General Hospital
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Chinese PLA General Hospital
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP