Persona Revision Knee System Outcomes
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-u
| Condition(s) | Arthroplasty Complications, Infection, Knee Disease, Knee Osteoarthritis |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 t |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Zimmer Biomet |
| Locations | Fayetteville, Arkansas, United States; Little Rock, Arkansas, United States; Fresno, California, United States; Superior, Colorado, United States; Evansville, Indiana, United States; Granger, Indiana, United States (+10 more sites) |
| Start date | 2021-06-14 |
| NCT ID | NCT04821154 |
| Official listing | https://clinicaltrials.gov/study/NCT04821154 |