Comparative Outcomes Between Imageless Robotic-assisted and Conventional Total Knee Arthroplasty

Navamindradhiraj University

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Device: Navio™ Robotics-assisted Surgical System, LEGION Total Knee System; Device: Conventional, LEGION Total Knee System

Study type: Interventional

Funder types: Other

Identifiers

NCT04307251

COA 012/2563

Details and patient eligibility

About

The purpose of this study is to compare post-operative mechanical alignment (Hip-Knee-Ankle angle; HKA) between imageless robotic-assisted (Navio™ Robotics-assisted Surgical System) and Conventional Total Knee Arthroplasty

Enrollment: 168 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty
• Age 50-80 year
• Patients with osteoarthritis who voluntarily participated in the project

Exclusion criteria

• Patients with osteoporosis
• History of inflammatory arthroplathy
• Previous fracture or open surgery on the same knee
• Patients with bilateral total knee arthroplasty
• Patients osteoarthritis with revision surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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168 participants in 2 patient groups

Navio™ Robotics-assisted Surgical System

Experimental group

Treatment:

Device: Navio™ Robotics-assisted Surgical System, LEGION Total Knee System

Conventional, non-robotics-assisted total knee surgical system

Experimental group

Treatment:

Device: Conventional, LEGION Total Knee System