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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)
Must not have
History of inflammatory arthropathy in the same knee
History of prior open knee surgery in the same knee
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
I have tried non-surgical treatments for 12 weeks without improvement.
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My knee pain is due to the most severe stage of arthritis.
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I am between 40 and 85 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had swelling or pain in the same knee before due to inflammation.
Select...
I have had open knee surgery on the same knee before.
Select...
I have a major tear in the ligaments on the inside or outside of my knee.
Select...
I have severe joint problems beyond just one knee affecting my movement.
Select...
My limb is bent more than 15 degrees from its normal straight position.
Select...
I have had surgery to change bone shape or a fracture near a joint.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Erythrocyte Indices
Score on the Timed Up and Go Test (TUG)
Secondary study objectives
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)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Who is running the clinical trial?
Smith & Nephew, Inc.Industry Sponsor
167 Previous Clinical Trials
22,045 Total Patients Enrolled
33 Trials studying Osteoarthritis
4,625 Patients Enrolled for Osteoarthritis
Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,663,104 Total Patients Enrolled
6 Trials studying Osteoarthritis
1,026 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had swelling or pain in the same knee before due to inflammation.I have had open knee surgery on the same knee before.I have tried non-surgical treatments for 12 weeks without improvement.I am willing and able to follow the study's requirements.My limb is bent more than 15 degrees from its normal straight position.I have had surgery to change bone shape or a fracture near a joint.I have a major tear in the ligaments on the inside or outside of my knee.Your body weight is not extremely high for your height.You can speak, read and understand English well.I have severe joint problems beyond just one knee affecting my movement.My knee pain is due to the most severe stage of arthritis.I have tried non-surgical treatments for 12 weeks without improvement.I am between 40 and 85 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Navio™ Robotics-assisted Surgical System
- Group 2: Non robotics-assisted Surgical System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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