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

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ClinicalTrials.gov Identifier: NCT03668756
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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

Condition or disease Intervention/treatment
Arthropathy of Knee Joint Procedure: Computer-Assisted Navigation TKA

Detailed Description:
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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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Computer-Assisted Navigation and Conventional Instrumentation for Bilateral Total Knee Arthroplasty: The Functional Outcome of Mid-Term Follow-up Study
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Group/Cohort Intervention/treatment
Computer-Assisted Navigation TKA
the patients who were received CAS TKA in one limb
Procedure: Computer-Assisted Navigation TKA
TKAs were performed using the image-free CAS navigation system VectorVision

Conventional TKA
the patients who were received conventional TKA in one limb



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668756


Locations
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Taiwan
Sports Medicine Center, Chang Gung Memorial Hospital
Pizi, Taiwan, 613
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Robert Wen-Wei HSU, MD Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03668756    
Other Study ID Numbers: CORPG6G0251
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases