Navio™ Robotics-assisted Surgical System for Osteoarthritis of the Knee

Phase-Based Progress Estimates
Columbia University Medical Center, New York, NYOsteoarthritis of the KneeNavio™ Robotics-assisted Surgical System - Device
40 - 85
All Sexes
What conditions do you have?

Study Summary

This trial will compare outcomes of robotic-assisted versus conventional total knee replacement surgery in patients with end stage arthritis of the knee.

Treatment Effectiveness

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Up to 2 years

Up to 2 years
Score on Global Rating Score of Knee Function (GRS)
Score on New Knee Society Scores (2011 KSS)
Score on Short-Form 12 Health Questionnaire (SF-12)
Erythrocyte Indices
Score on the Timed Up and Go Test (TUG)

Trial Safety

Trial Design

2 Treatment Groups

Non robotics-assisted Surgical System
1 of 2
Navio™ Robotics-assisted Surgical System
1 of 2

Active Control

Experimental Treatment

86 Total Participants · 2 Treatment Groups

Primary Treatment: Navio™ Robotics-assisted Surgical System · No Placebo Group · N/A

Navio™ Robotics-assisted Surgical System
Experimental Group · 1 Intervention: Navio™ Robotics-assisted Surgical System · Intervention Types: Device
Non robotics-assisted Surgical SystemNoIntervention Group · 1 Intervention: Non robotics-assisted Surgical System · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,314 Previous Clinical Trials
1,623,912 Total Patients Enrolled
Smith & Nephew, Inc.Industry Sponsor
157 Previous Clinical Trials
21,756 Total Patients Enrolled
6 Trials studying Osteoarthritis of the Knee
879 Patients Enrolled for Osteoarthritis of the Knee
Herbert John Cooper, MDPrincipal Investigator - Columbia University
Lenox Hill Hospital
Medical School - Columbia University, Doctor of Medicine
Lenox Hill Hospital, Residency in Orthopedic Surgery

Eligibility Criteria

Age 40 - 85 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have tried non-surgical treatments for at least 12 weeks, but they did not work.
You can speak, read and understand English well.
Your body weight is not extremely high for your height.

Frequently Asked Questions

Are individuals currently being accepted for this investigation?

"According to this research is currently enrolling patients with the original posting date of April 17th, 2019 and most recent change being on March 11th, 2022." - Anonymous Online Contributor

Unverified Answer

Does my medical history qualify me for enrollment in this trial?

"This trial requires 86 participants aged 40 to 85 who suffer from osteoarthritis of the knee. Furthermore, their BMI must be lower than 40.0 kg/m^2 and they must have undergone a minimum 12 weeks of nonoperative management before enrolment. Additionally, these candidates need to possess fluency in English language." - Anonymous Online Contributor

Unverified Answer

How many volunteers are participating in this research trial?

"Affirmative. indicates that this clinical trial, which first appeared on April 17th 2019, is actively seeking participants. The recruitment goal is to enlist 86 volunteers at a single medical centre." - Anonymous Online Contributor

Unverified Answer

Is this research project open to minors?

"According to the rules of this medical trial, only individuals within the age range of 40-85 years old can be considered for enrollment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.