An observational study in Arthropathy of Knee Joint, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2018-09-13.
Sponsored by Chang Gung Memorial Hospital · Observational
To compare the functional outcomes of Computer-Assisted Navigation (CAS) and Conventional Instrumentation TKA at the 8-year follow-up.
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.
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This study's enrollment of 56 is below the median of 100 across 216 observational studies indexed under Joint Diseases.
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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:
-
the patients who were received CAS TKA in one limb
Procedure: Computer-Assisted Navigation TKA
the patients who were received conventional TKA in one limb
TKAs were performed using the image-free CAS navigation system VectorVision
International Knee Society (IKS)
To assess the functional outcome of TKA by self-explanatory questionnaire
Time frame: up to 8-year follow-up
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)
Time frame: Baseline and 3 months after operation
Hospital for Special Surgery (HSS) Questionnaire
To assess the functional outcome of TKA by self-explanatory questionnaire
Time frame: Baseline, 8-year follow-up
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
To assess the functional outcome of TKA by self-explanatory questionnaire
Time frame: Baseline, 8-year follow-up
Short Form-36 (SF-36) Health Survey
To assess the functional outcome of TKA by self-explanatory questionnaire
Time frame: Baseline, 8-year follow-up
Plan to share: No
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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital