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

N

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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