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Completed

NCT Number: NCT04307251

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

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

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Navamindradhiraj University

Dusit, Bangkok, 10300, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Mechanical axis

    Time frame: 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 outcomes

  1. Knee Society and Knee Society function score

    Time frame: 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)

  2. Range of motion of knee

    Time frame: 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)

  3. Oxford knee score

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

    Oxford knee score (minimum 0, maximum 48)

Sponsors and collaborators

Lead sponsor

Navamindradhiraj University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 13, 2020
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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