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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Navio™ Robotics-assisted Surgical System, LEGION Total Knee System
Conventional, LEGION Total Knee System
Sponsored by
Navamindradhiraj University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Navamindradhiraj University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Navio™ Robotics-assisted Surgical System

Conventional, non-robotics-assisted total knee surgical system

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Knee Society and Knee Society function score
Knee Society and Knee Society function score (minimum 0, maximum 200)
Range of motion of knee
Range of motion of knee (minimum 0, maximum 140)
Oxford knee score
Oxford knee score (minimum 0, maximum 48)

Full Information

First Posted
February 28, 2020
Last Updated
April 21, 2022
Sponsor
Navamindradhiraj University
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1. Study Identification

Unique Protocol Identification Number
NCT04307251
Brief Title
Comparative Outcomes Between Imageless Robotic-assisted and Conventional Total Knee Arthroplasty
Official Title
Comparative Outcomes Between Imageless Robotic-assisted and Conventional Total Knee Arthroplasty : A Prospective, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 23, 2020 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
February 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Navamindradhiraj University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Navio™ Robotics-assisted Surgical System
Arm Type
Experimental
Arm Title
Conventional, non-robotics-assisted total knee surgical system
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Navio™ Robotics-assisted Surgical System, LEGION Total Knee System
Intervention Description
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
Intervention Name(s)
Conventional, LEGION Total Knee System
Intervention Description
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 Outcome Measure Information:
Title
Mechanical axis
Description
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 Outcome Measure Information:
Title
Knee Society and Knee Society function score
Description
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
Title
Range of motion of knee
Description
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
Title
Oxford knee score
Description
Oxford knee score (minimum 0, maximum 48)
Time Frame
Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satit Thiengwittayaporn, M.D.
Organizational Affiliation
Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Navamindradhiraj University
City
Dusit
State/Province
Bangkok
ZIP/Postal Code
10300
Country
Thailand

12. IPD Sharing Statement

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

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