Application of Computer-assisted Navigation in Total Knee Arthroplasty: A Randomized Pair-matched Double-blind Trial
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observational
N/A
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2009
CompletedFirst Posted
Study publicly available on registry
September 23, 2009
CompletedSeptember 23, 2009
September 1, 2009
September 22, 2009
September 22, 2009
Conditions
Eligibility Criteria
the subjects who had been scheduled for simultaneous bilateral TKA,
You may qualify if:
- plan for simultaneous bilateral TKA.
You may not qualify if:
- plan for unilateral TKA.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 22, 2009
First Posted
September 23, 2009
Last Updated
September 23, 2009
Record last verified: 2009-09