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

Study Overview
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Brief Summary
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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

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Navio™ Robotics-assisted Surgical System, LEGION Total Knee System
* Device: Conventional, LEGION Total Knee System


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Navio™ Robotics-assisted Surgical System<br> | Device: Navio™ Robotics-assisted Surgical System, LEGION Total Knee System<br>* 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.<br>|
| Experimental: Conventional, non-robotics-assisted total knee surgical system<br> | Device: Conventional, LEGION Total Knee System<br>* 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.<br>|

What is the study measuring?
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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 | 
| 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 | 
| 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 |