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

NCT04307251 | Completed FDA Device

• 1 other identifier: COA 012/2563
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Range of motion of knee

  Change from baseline Range of motion of knee at 3 months, 6 months, and 12 months after surgery

• Oxford knee score

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

Study Arms (2)

Navio™ Robotics-assisted Surgical System

EXPERIMENTAL

Device: Navio™ Robotics-assisted Surgical System, LEGION Total Knee System

Conventional, non-robotics-assisted total knee surgical system

EXPERIMENTAL

Device: Conventional, LEGION Total Knee System

Interventions

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

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.

Navio™ Robotics-assisted Surgical System

Conventional, LEGION Total Knee System DEVICE

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.

Conventional, non-robotics-assisted total knee surgical system

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Navamindradhiraj University: lead

Study Sites (1)

Navamindradhiraj University

Dusit, Bangkok, 10300, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Satit Thiengwittayaporn, M.D.

  Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 13, 2020
• Study Start: March 23, 2020
• Primary Completion: January 30, 2021
• Study Completion: February 25, 2021
• Last Updated: April 22, 2022

Record last verified: 2020-03

Locations

TH (1)