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

Completed

• Conditions: Arthropathy of Knee Joint
• Interventions: Procedure: Computer-Assisted Navigation TKA

• Registration Number: NCT03668756
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-11-01
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2018-09
• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-12
• Last Update Submitted: 2018-09-12
• Study First Posted: 2018-09-13
• Last Update Posted: 2018-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Computer-Assisted Navigation TKA	Computer-Assisted Navigation TKA	the patients who were received CAS TKA in one limb

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Hospital for Special Surgery (HSS) Questionnaire	Baseline, 8-year follow-up	To assess the functional outcome of TKA by self-explanatory questionnaire
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)	Baseline, 8-year follow-up	To assess the functional outcome of TKA by self-explanatory questionnaire
Short Form-36 (SF-36) Health Survey	Baseline, 8-year follow-up	To assess the functional outcome of TKA by self-explanatory questionnaire
Radiographic evaluation	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)

Trial Locations

Locations (1)

Sports Medicine Center, Chang Gung Memorial Hospital; 🇨🇳 Pizi, Taiwan