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

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

Study Overview

• Status: Completed
• Conditions: Arthropathy of Knee Joint
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• Taiwan
  • Pizi, Taiwan, 613
    • Sports Medicine Center, Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Knee Society (IKS)	To assess the functional outcome of TKA by self-explanatory questionnaire	up to 8-year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline and 3 months after operation
Hospital for Special Surgery (HSS) Questionnaire	To assess the functional outcome of TKA by self-explanatory questionnaire	Baseline, 8-year follow-up
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)	To assess the functional outcome of TKA by self-explanatory questionnaire	Baseline, 8-year follow-up
Short Form-36 (SF-36) Health Survey	To assess the functional outcome of TKA by self-explanatory questionnaire	Baseline, 8-year follow-up

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Robert Wen-Wei HSU, MD, Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): September 13, 2018
• Last Update Submitted That Met QC Criteria: September 12, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: CORPG6G0251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No