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Clinical Trials/NCT03668756
NCT03668756
Completed
N/A

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

Chang Gung Memorial Hospital1 site in 1 country56 target enrollmentNovember 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Arthropathy of Knee Joint
Sponsor
Chang Gung Memorial Hospital
Enrollment
56
Locations
1
Primary Endpoint
International Knee Society (IKS)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2017
End Date
August 31, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility 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

  • Not provided

Outcomes

Primary Outcomes

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

  • Hospital for Special Surgery (HSS) Questionnaire(Baseline, 8-year follow-up)
  • Western Ontario and McMaster University Osteoarthritis Index (WOMAC)(Baseline, 8-year follow-up)
  • Short Form-36 (SF-36) Health Survey(Baseline, 8-year follow-up)
  • Radiographic evaluation(Baseline and 3 months after operation)

Study Sites (1)

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