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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03668756
Enrollment
56
Registered
2018-09-13
Start date
2017-11-01
Completion date
2018-08-31
Last updated
2018-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy of Knee Joint

Brief summary

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

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.

Interventions

PROCEDUREComputer-Assisted Navigation TKA

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

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
International Knee Society (IKS)up to 8-year follow-upTo assess the functional outcome of TKA by self-explanatory questionnaire

Secondary

MeasureTime frameDescription
Radiographic evaluationBaseline and 3 months after operationStandard 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)
Hospital for Special Surgery (HSS) QuestionnaireBaseline, 8-year follow-upTo assess the functional outcome of TKA by self-explanatory questionnaire
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)Baseline, 8-year follow-upTo assess the functional outcome of TKA by self-explanatory questionnaire
Short Form-36 (SF-36) Health SurveyBaseline, 8-year follow-upTo assess the functional outcome of TKA by self-explanatory questionnaire

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026