RECRUITING

Persona Revision Knee System Outcomes

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

The study will evaluate the performance, clinical benefits and safety of the Persona Revision Knee System in patients who have received primary or revision total knee arthroplasty (TKA) treatment. This will be done using a multicenter, single-arm, consecutive series, retrospective cohort study with prospective follow-up.

Official Title

Clinical Investigation to Demonstrate Performance, Safety and Clinical Benefits of the Persona Revision Knee System

Quick Facts

Study Start:2021-06-14
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04821154

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. Male or female of at least 18 years of age at the time of screening.
  2. 2. Signed an institutional review board approved informed consent.
  3. 3. Willingness and ability to comply with the study procedures and visit schedules and ability to understand and follow oral and written post-operative care instructions.
  4. 4. Previous medical diagnosis/ history of at least one of the following conditions requiring treatment using the Persona Revision Knee System within a pre-specified study variant configuration (cohort), in accordance with the instructions for use (IFU):
  5. 1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis or polyarthritis
  6. 2. Collagen disorders, and/or avascular necrosis of the femoral condyle
  7. 3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
  8. 4. Moderate valgus, varus, or flexion deformities
  9. 5. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery
  10. 5. A pre-operative Knee Society Knee Score (objective assessment) ≤ 80.
  1. 1. An ulcer of the skin
  2. 2. History of recurrent breakdown of the skin
  3. 3. Use of steroids 9) Patient requires simultaneous bilateral knee surgery for treatment of diagnosed condition.

Contacts and Locations

Study Contact

Chelsea Smith
CONTACT
714-740-9438
chelsea.smith2@zimmerbiomet.com
Charles Jaggard
CONTACT
charles.jaggard@zimmerbiomet.com

Principal Investigator

Charles Jaggard
STUDY_DIRECTOR
Zimmer Biomet

Study Locations (Sites)

Advanced Orthopaedic Specialists
Fayetteville, Arkansas, 72703
United States
Bowen Hefley Orthopedics
Little Rock, Arkansas, 72205
United States
Community Foundation Medical Group
Fresno, California, 93720
United States
Cornerstone Orthopaedics & Sports Medicine
Superior, Colorado, 80027
United States
Orthopaedic Associates, Inc.
Evansville, Indiana, 47710
United States
Jeff Yergler, LLC
Granger, Indiana, 46530
United States
Arthroplasty Foundation Inc.
Louisville, Kentucky, 40220
United States
Ascension Providence Rochester Hospital
Rochester, Michigan, 48307
United States
Michigan Orthopaedic Surgeons, PLLC
Southfield, Michigan, 48076
United States
TRIA Orthopaedic Center Research Institute
Bloomington, Minnesota, 55431
United States
Thomas Aleto MD, PC
Columbia, Missouri, 65201
United States
Orthopaedic Research Institute of New Jersey
Chester, New Jersey, 07390
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
ROC Orthopedics
Oregon City, Oregon, 97045
United States
Penn Medicine/ Lancaster General Health
Lancaster, Pennsylvania, 17602
United States
Ortopedic Surgeons of Wisconsin, SC
Wauwatosa, Wisconsin, 53222
United States

Collaborators and Investigators

Sponsor: Zimmer Biomet

  • Charles Jaggard, STUDY_DIRECTOR, Zimmer Biomet

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 Date2021-06-14
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2021-06-14
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Revision
  • Total Knee
  • Medical Device
  • Safety
  • Performance
  • Primary
  • Clinical Benefits

Additional Relevant MeSH Terms

  • Arthroplasty Complications
  • Infection
  • Knee Disease
  • Knee Osteoarthritis