Persona Revision Knee System Outcomes

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.

Conditions

Arthroplasty Complications, Infection, Knee Disease, Knee Osteoarthritis

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Study Overview

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Study Details

Study overview

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.

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

Persona Revision Knee System Outcomes

Condition
Arthroplasty Complications
Intervention / Treatment

-

Contacts and Locations

Fayetteville

Advanced Orthopaedic Specialists, Fayetteville, Arkansas, United States, 72703

Little Rock

Bowen Hefley Orthopedics, Little Rock, Arkansas, United States, 72205

Fresno

Community Foundation Medical Group, Fresno, California, United States, 93720

Superior

Cornerstone Orthopaedics & Sports Medicine, Superior, Colorado, United States, 80027

Evansville

Orthopaedic Associates, Inc., Evansville, Indiana, United States, 47710

Granger

Jeff Yergler, LLC, Granger, Indiana, United States, 46530

Louisville

Arthroplasty Foundation Inc., Louisville, Kentucky, United States, 40220

Rochester

Ascension Providence Rochester Hospital, Rochester, Michigan, United States, 48307

Southfield

Michigan Orthopaedic Surgeons, PLLC, Southfield, Michigan, United States, 48076

Bloomington

TRIA Orthopaedic Center Research Institute, Bloomington, Minnesota, United States, 55431

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male or female of at least 18 years of age at the time of screening.
  • 2. Signed an institutional review board approved informed consent.
  • 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. 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):
  • 1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis or polyarthritis
  • 2. Collagen disorders, and/or avascular necrosis of the femoral condyle
  • 3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
  • 4. Moderate valgus, varus, or flexion deformities
  • 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
  • 5. A pre-operative Knee Society Knee Score (objective assessment) ≤ 80.
  • 1. An ulcer of the skin
  • 2. History of recurrent breakdown of the skin
  • 3. Use of steroids 9) Patient requires simultaneous bilateral knee surgery for treatment of diagnosed condition.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Zimmer Biomet,

Charles Jaggard, STUDY_DIRECTOR, Zimmer Biomet

Study Record Dates

2027-12-31