← Back to Search

Robotic Surgery

Robotic-Assisted Knee Replacement for Osteoarthritis

N/A
Recruiting
Led By Herbert John Cooper, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Failure of a minimum 12 weeks of nonoperative management
End-stage knee osteoarthritis (Kellgren and Lawrence grade 4)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

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.

Who is the study for?
This trial is for individuals aged 40-85 with severe knee osteoarthritis who haven't improved after at least 12 weeks of non-surgical treatment. Participants must have a BMI under 40, speak English fluently, and not have had previous open knee surgery or other major knee issues.Check my eligibility
What is being tested?
The study compares robotic-assisted total knee replacement using the Navio system to conventional surgery. Both groups receive identical care and implants but differ in surgical technique. Patients will undergo x-rays and complete tests to assess their surgery's success.See study design
What are the potential side effects?
While specific side effects are not listed for the Navio system, typical risks of knee replacement include pain, swelling, infection risk at the incision site, blood clots, implant problems like loosening or wear, and possible need for additional surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have tried non-surgical treatments for 12 weeks without improvement.
Select...
My knee pain is due to the most severe stage of arthritis.
Select...
I am between 40 and 85 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Erythrocyte Indices
Score on the Timed Up and Go Test (TUG)
Secondary outcome measures
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)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Navio™ Robotics-assisted Surgical SystemExperimental Treatment1 Intervention
Navio™ Robotics-assisted Surgical System
Group II: Non robotics-assisted Surgical SystemActive Control1 Intervention
Conventional, non-robotics-assisted total knee surgical system

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,433 Previous Clinical Trials
2,460,929 Total Patients Enrolled
6 Trials studying Osteoarthritis
1,025 Patients Enrolled for Osteoarthritis
Smith & Nephew, Inc.Industry Sponsor
165 Previous Clinical Trials
22,395 Total Patients Enrolled
32 Trials studying Osteoarthritis
4,638 Patients Enrolled for Osteoarthritis
Herbert John Cooper, MDPrincipal Investigator - Columbia University
Lenox Hill Hospital
Medical School - Columbia University, Doctor of Medicine
Lenox Hill Hospital, Residency in Orthopedic Surgery

Media Library

Navio™ Robotics-assisted Surgical System (Robotic Surgery) Clinical Trial Eligibility Overview. Trial Name: NCT03519269 — N/A
Osteoarthritis Research Study Groups: Navio™ Robotics-assisted Surgical System, Non robotics-assisted Surgical System
Osteoarthritis Clinical Trial 2023: Navio™ Robotics-assisted Surgical System Highlights & Side Effects. Trial Name: NCT03519269 — N/A
Navio™ Robotics-assisted Surgical System (Robotic Surgery) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03519269 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently being accepted for this investigation?

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

Answered by AI

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."

Answered by AI

How many volunteers are participating in this research trial?

"Affirmative. Clinicaltrials.gov 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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Columbia University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Navio Robotic Versus Conventional Total Knee Arthroplasty
Herbert John Cooper, MD 2019. "Navio Robotic Versus Conventional Total Knee Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03519269.
All > Osteoarthritis Knee > Knee Replacement
~21 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top