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

Completed

• Conditions: Knee Arthritis

• Registration Number: NCT00982956
• Lead Sponsor: Chinese PLA General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-09
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-22
• Last Update Submitted: 2009-09-22
• Study First Posted: 2009-09-23
• Last Update Posted: 2009-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• plan for simultaneous bilateral TKA.

Exclusion Criteria

• plan for unilateral TKA.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified