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Recruiting NCT04821154

Persona Revision Knee System Outcomes

Trial Parameters

Condition Arthroplasty Complications
Sponsor Zimmer Biomet
Study Type OBSERVATIONAL
Phase N/A
Enrollment 380
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-06-14
Completion 2027-12-31
Interventions
Persona Revision Knee System

Brief Summary

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.

Eligibility Criteria

Inclusion 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 satisfa

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