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

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Navio™ Robotics-assisted Surgical System, LEGION Total Knee System; Device: Conventional, LEGION Total Knee System

• Registration Number: NCT04307251
• Lead Sponsor: Navamindradhiraj University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-28
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-13
• Study Start: 2020-03-23
• Primary Completion: 2021-01-30
• Study Completion: 2021-02-25
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Navio™ Robotics-assisted Surgical System	Navio™ Robotics-assisted Surgical System, LEGION Total Knee System	-
Conventional, non-robotics-assisted total knee surgical system	Conventional, LEGION Total Knee System	-

Primary Outcome Measures

Name	Time	Method
Mechanical axis	Change from baseline mechanical axis at 6 weeks after surgery	Post-operative Mechanical Alignment; Hip-Knee-Ankle angle; If you divide the knee into quadrants, the ideal mechanical axis would bisect the knee (0), with medial zone (-1) or lateral zone (-1) being within physiologic range. With the notable exception of physiologic varus \<age 2 and physiologic valgus \<age 6, medial or lateral zones 2 or 3 would likely manifest symptoms and gait disturbance and thereby warrant surgical intervention

Secondary Outcome Measures

Name	Time	Method
Knee Society and Knee Society function score	Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery	Knee Society and Knee Society function score (minimum 0, maximum 200)
Range of motion of knee	Change from baseline Range of motion of knee at 3 months, 6 months, and 12 months after surgery	Range of motion of knee (minimum 0, maximum 140)
Oxford knee score	Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery	Oxford knee score (minimum 0, maximum 48)

Trial Locations

Locations (1)

Navamindradhiraj University; 🇹🇭 Dusit, Bangkok, Thailand