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

NCT ID: NCT04307251

Last Updated: 2022-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-23

Study Completion Date

2021-02-25

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

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Navio™ Robotics-assisted Surgical System

Group Type EXPERIMENTAL

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

Intervention Type 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, non-robotics-assisted total knee surgical system

Group Type EXPERIMENTAL

Conventional, LEGION Total Knee System

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Navamindradhiraj University

OTHER

Sponsor Role lead

Responsible Party

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Satit Thiengwittayaporn

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Satit Thiengwittayaporn, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Navamindradhiraj University

Dusit, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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COA 012/2563

Identifier Type: -

Identifier Source: org_study_id

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