Persona Revision Knee System Outcomes
Brief description of study
This study evaluates 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. The study
reviews the Persona® Revision Knee System (K181947 and K191625) implants and
instrumentation, and any compatible devices also being used.
Detailed description of study
The study is designed for retrospective data collection along
with prospective follow-up. Study team members identify patients who underwent
primary or revision TKA with this system and invite them to participate. If
they consent to join the study, they will come to the study site at the
following times for follow-up visits: 6 months, 12 months, and then annually at
2, 3, 4, and 5 years post-implant. These follow-up visits include a knee exam,
x-ray, and questionnaires.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Arthroplasty Complications, Knee Disease, Knee Osteoarthritis, Knee Replacement
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria:
- Willingness and ability to follow the study procedures and visit schedules
- Ability
to understand and follow verbal and written post-operative care instructions
- Previous
diagnosis or history of at least one of the study conditions requiring
treatment using the Persona Revision Knee System
Exclusion Criteria:
- Previous history of infection in the affected joint that may affect the prosthetic joint
- Diagnosed
with neuropathic arthropathy, osteoporosis, or any loss of musculature or
neuromuscular disease that compromises the affected limb
- Diagnosis of rheumatoid arthritis in conjunction with any of the following at the time of screening:o An ulcer of the skino History of recurrent breakdown of the skino Use of steroids
- Pregnant or planning to become pregnant during the time they will be participating in the study
Updated on
09 Mar 2024.
Study ID: 2021-46
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