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Prosthetic Device
Robotic-Assisted Knee Replacement Designs for Total Knee Replacement
N/A
Recruiting
Led By Vinay Aggarwal, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients scheduled for an elective primary TKA for a diagnosis of osteoarthritis or inflammatory arthritis using the ROSA Knee System
Patients ≥18 years of age
Must not have
History of prior open surgery with significant hardware in place on the affected knee (i.e. prior distal femur or proximal tibia fracture or osteotomy)
Preoperative diagnosis of post-traumatic arthritis, avascular necrosis, or fracture
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 20
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two types of knee replacement surgery using a robotic system. Results will be tracked up to 5 years.
Who is the study for?
This trial is for adults over 18 who need a knee replacement due to osteoarthritis or inflammatory arthritis and are willing to follow the study's protocol. They must be scheduled for surgery using the ROSA robotic system and have access to a device that works with an Apple Watch and mymobility App.
What is being tested?
The study compares two types of knee implant devices: Persona Medial Congruent (MC) versus Posterior-Stabilized (PS), both performed with the ROSA robotic system. Participants will be monitored for up to five years after their surgeries.
What are the potential side effects?
While specific side effects aren't listed, typical risks associated with knee replacement may include pain, swelling, infection risk at the surgical site, blood clots, stiffness in the knee joint, and possible wear or malfunction of prosthetic components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a knee replacement due to arthritis using the ROSA Knee System.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had major knee surgery with metal implants.
Select...
I have been diagnosed with arthritis, bone death, or a fracture due to injury before surgery.
Select...
I have had an infection in my knee before.
Select...
I am having or have had a second knee replacement surgery.
Select...
I am unable to sign a consent form.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 20
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 20
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
European Quality of Life Five Dimension (EQ-5D) Score
Forgotten Joint Score (FJS)
Estrogen Replacement Therapy
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: Total Knee Arthroplasty (TKA) performed using a medial congruent articular bearing surface designExperimental Treatment1 Intervention
Group II: Total Knee Arthroplasty (TKA) performed using a posterior stabilized bearing designActive Control1 Intervention
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,415 Previous Clinical Trials
856,177 Total Patients Enrolled
Vinay Aggarwal, MDPrincipal InvestigatorNYU Langone Health