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Completed

NCT Number: NCT03668756

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

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

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Key information

Conditions

Arthropathy of Knee Joint

Sex eligibility

All sexes

Study type

Observational

Primary location

Sports Medicine Center, Chang Gung Memorial Hospital

Pizi, 613, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Computer-Assisted Navigation TKA

Procedure

TKAs were performed using the image-free CAS navigation system VectorVision

Primary outcomes

  1. International Knee Society (IKS)

    Time frame: up to 8-year follow-up

    To assess the functional outcome of TKA by self-explanatory questionnaire

Secondary outcomes

  1. Radiographic evaluation

    Time frame: Baseline and 3 months after operation

    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)

  2. Hospital for Special Surgery (HSS) Questionnaire

    Time frame: Baseline, 8-year follow-up

    To assess the functional outcome of TKA by self-explanatory questionnaire

  3. Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

    Time frame: Baseline, 8-year follow-up

    To assess the functional outcome of TKA by self-explanatory questionnaire

  4. Short Form-36 (SF-36) Health Survey

    Time frame: Baseline, 8-year follow-up

    To assess the functional outcome of TKA by self-explanatory questionnaire

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2018
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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