Comparison of Computer-Assisted Navigation and Conventional Instrumentation for Bilateral Total Knee Arthroplasty

Study Overview
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Brief Summary
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To compare the functional outcomes of Computer-Assisted Navigation (CAS) and Conventional Instrumentation TKA at the 8-year follow-up.

Detailed Description
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The data of the present study was collected from the review of the medical chart of the patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive Computer-Assisted Navigation (CAS) TKA in one limb and conventional TKA. Then, comparing the functional outcomes of CAS and Conventional Instrumentation was performed by statistical software.

Official Title
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Comparison of Computer-Assisted Navigation and Conventional Instrumentation for Bilateral Total Knee Arthroplasty: The Functional Outcome of Mid-Term Follow-up Study

Conditions
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Arthropathy of Knee Joint

Intervention / Treatment
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* Procedure: Computer-Assisted Navigation TKA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive CAS TKA in one limb and conventional TKA in the other at the 8-year follow-up. Exclusion Criteria: -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Computer-Assisted Navigation TKA<br>the patients who were received CAS TKA in one limb | Procedure: Computer-Assisted Navigation TKA<br>* TKAs were performed using the image-free CAS navigation system VectorVision<br>|
| Conventional TKA<br>the patients who were received conventional TKA in one limb | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Knee Society (IKS) | To assess the functional outcome of TKA by self-explanatory questionnaire | up to 8-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic evaluation | Standard anteroposterior, lateral radiographs of the knee and standing long-leg radiographs of the lower extremity were obtained pre- and postoperatively. The lower extremities were fully extended so that the tibial tuberosities were facing forward and the lateral malleoli were 15 cm apart to ensure that the tibia was vertical and facing forward with minimal rotation. The X-ray beam (20-25 mA/s; 80-85 kV) was centered at the knee joint level at a distance of 120-140 cm.Radiographic data included the mechanical axis angle and the four component alignments described by Ewald: the femoral valgus (FV) angle; tibial valgus angle (TV); femoral flexion (FF) angle; and tibial flexion angle (TF) | Baseline and 3 months after operation | 
| Hospital for Special Surgery (HSS) Questionnaire | To assess the functional outcome of TKA by self-explanatory questionnaire | Baseline, 8-year follow-up | 
| Western Ontario and McMaster University Osteoarthritis Index (WOMAC) | To assess the functional outcome of TKA by self-explanatory questionnaire | Baseline, 8-year follow-up | 
| Short Form-36 (SF-36) Health Survey | To assess the functional outcome of TKA by self-explanatory questionnaire | Baseline, 8-year follow-up |