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

NCT04307251 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2022-04-22

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Navamindradhiraj University

    lead OTHER

Principal Investigators

  • Satit Thiengwittayaporn, M.D. · Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-23
Primary Completion
2021-01-30
Completion
2021-02-25
FDA Device
Yes

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04307251 on ClinicalTrials.gov