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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year 20

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

Select...

I am scheduled for a knee replacement due to arthritis using the ROSA Knee System.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 20

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year 20

This trial's timeline: 3 weeks for screening, Varies for treatment, and year 20 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

European Quality of Life Five Dimension (EQ-5D) Score

Forgotten Joint Score (FJS)

Estrogen Replacement Therapy

Secondary outcome measures

Change in Average daily flight count

Change in Average daily step count

Change in Average gait speed

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,369 Previous Clinical Trials

840,398 Total Patients Enrolled

Vinay Aggarwal, MDPrincipal InvestigatorNYU Langone Health

Frequently Asked Questions

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

How many subjects are participating in this clinical experiment?

"Indeed, clinicaltrials.gov reveals that this medical research project is still recruiting. Beginning on September 27th 2023 and last updated November 6th 2023, the trial seeks to include 200 patients from a single site."

Answered by AI

Are there any current openings in this investigation?

"As indicated by information hosted on clinicaltrials.gov, the investigation is ongoing and recruiting for patients. This trial was initially published on September 27th 2023 and has been amended since November 6th of that same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Persona MC vs PS RCT With ROSA

2023. "Persona MC vs PS RCT With ROSA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05391828.

All > Knee Replacement