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

Navamindradhiraj University168 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

168

Conditions

Osteoarthritis, Knee

Interventions

Navio™ Robotics-assisted Surgical System, LEGION Total Knee SystemDEVICE

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.

Conventional, LEGION Total Knee SystemDEVICE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Navamindradhiraj University

Dusit, Bangkok, Thailand

Outcomes

Primary Outcomes

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

Time frame: Change from baseline mechanical axis at 6 weeks after surgery

Secondary Outcomes

Knee Society and Knee Society function score

Knee Society and Knee Society function score (minimum 0, maximum 200)

Time frame: 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)

Time frame: 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)

Time frame: Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery

Data from ClinicalTrials.gov

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