Clinical Investigation to Demonstrate Performance, Safety and Clinical Benefits of the Persona Revision Knee System
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.
• Male or female of at least 18 years of age at the time of screening.
• Signed an institutional review board approved informed consent.
• 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.
• 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):
‣ Rheumatoid arthritis, osteoarthritis, traumatic arthritis or polyarthritis
⁃ Collagen disorders, and/or avascular necrosis of the femoral condyle
⁃ Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
⁃ Moderate valgus, varus, or flexion deformities
⁃ 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
• A pre-operative Knee Society Knee Score (objective assessment) ≤ 80.