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

Comparative Outcomes Between Imageless Robotic-assisted and Conventional Total Knee Arthroplasty : A Prospective, Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Navio™ Robotics-assisted Surgical System, LEGION Total Knee System; Device: Conventional, LEGION Total Knee System

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Dusit, Bangkok, Thailand, 10300
      • Navamindradhiraj University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Navio™ Robotics-assisted Surgical System	Device: Navio™ Robotics-assisted Surgical System, LEGION Total Knee System; Robotic TKA uses computer software to convert anatomical information into a virtual patient-specific 3D reconstruction of the knee joint.The surgeon uses this virtual model to plan optimal bone resection, implant positioning, bone coverage, and limb alignment based on the patient's unique anatomy.
Experimental: Conventional, non-robotics-assisted total knee surgical system	Device: Conventional, LEGION Total Knee System; Total Knee Arthroplasty (TKA) is a widespread orthopaedic procedure for restoring functionality and minimizing pain due to end stage osteoarthritis. Conventional TKA, well-accepted as the standard of care, is performed with manual instrumentation guided by intramedullary or extramedullary alignment rods, as well as rotational guides that are not patient-specific.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical axis	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	Change from baseline mechanical axis at 6 weeks after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Navamindradhiraj University

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2020
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): February 25, 2021

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: COA 012/2563

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes