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

Arthropathy of Knee Joint Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03668756
• Other study ID #: CORPG6G0251
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: September 2018
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Arthropathy of Knee Joint
• Joint Diseases

Intervention

Procedure:
• Computer-Assisted Navigation TKA
TKAs were performed using the image-free CAS navigation system VectorVision

Locations

Country	Name	City	State
Taiwan	Sports Medicine Center, Chang Gung Memorial Hospital	Pizi

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Knee Society (IKS)	To assess the functional outcome of TKA by self-explanatory questionnaire	up to 8-year follow-up
Secondary	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
Secondary	Hospital for Special Surgery (HSS) Questionnaire	To assess the functional outcome of TKA by self-explanatory questionnaire	Baseline, 8-year follow-up
Secondary	Western Ontario and McMaster University Osteoarthritis Index (WOMAC)	To assess the functional outcome of TKA by self-explanatory questionnaire	Baseline, 8-year follow-up
Secondary	Short Form-36 (SF-36) Health Survey	To assess the functional outcome of TKA by self-explanatory questionnaire	Baseline, 8-year follow-up