RECRUITING

Persona MC vs PS RCT With ROSA

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Conditions

Total Knee Arthroplasty

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A randomized, controlled study comparing two total knee implant devices, Persona medial congruent (MC) vs posterior stabilized (PS). These surgeries will be performed using the ROSA robotic system. Patients will be followed up to 5 years.

Official Title

Randomized Control Trial Comparing Zimmer Biomet Persona Medial Congruent Versus Posterior Stabilized Total Knee Arthroplasty for Treatment of Knee Arthritis Using the ROSA Knee System

Quick Facts

Study Start:2023-09-27
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05391828

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients ≥18 years of age
  2. 2. Patients scheduled an elective primary TKA for a diagnosis of osteoarthritis or inflammatory arthritis using the ROSA Knee System.
  3. 3. Patient is willing to cooperate and follow study protocol and visit schedule
  4. 4. Subject has access to a device is capable of pairing to the Apple Watch, supporting application updates and is compatible with the mymobility App.
  1. 1. Patient is pregnant
  2. 2. Patient is unable to provide written consent
  3. 3. Revision TKA
  4. 4. History of prior infection in the affected knee
  5. 5. 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)
  6. 6. Preoperative diagnosis of post-traumatic arthritis, avascular necrosis, or fracture

Contacts and Locations

Study Contact

Vinay Aggarwal, MD
CONTACT
202 250 0679
Vinay.Aggarwal@nyulangone.org
Daniel Waren
CONTACT
954 559 2251
Daniel.Waren@nyulangone.org

Principal Investigator

Vinay Aggarwal, MD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Vinay Aggarwal, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-27
Study Completion Date2026-12

Study Record Updates

Study Start Date2023-09-27
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Total Knee Arthroplasty