The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty
The study design is a prospective, multicenter data collection model of the 510(k) cleared Persona Total Knee System. The study will require each site to obtain institutional review board (IRB) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process. All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty (TKA). Investigators will collect clinical data for a required 5 years. Follow-up clinical visits include 3 months, 1, 2, 5, 7 and 10 years post-operatively. Specific assessments include: 1. Confirming the safety, performance and clinical benefits of the Persona total knee system and instrumentation in primary and revision TKA. 2. Verifying that, under normal use, the performance and clinical benefits of this device and its instrumentation conform to those intended by the manufacturer by recording patient-reported clinical outcomes measures (PROMs) and radiographic outcomes (if available).
Study Type
OBSERVATIONAL
Enrollment
760
Total knee replacement.
Denver Hip & Knee, Inc.
Parker, Colorado, United States
RECRUITINGFoundation for Orthopaedic Research & Education
Tampa, Florida, United States
RECRUITINGNorthside Hospital, Inc.
Atlanta, Georgia, United States
ACTIVE_NOT_RECRUITINGU of L Health
Louisville, Kentucky, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
ACTIVE_NOT_RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGMississippi Sports Medicine and Orthopaedic Center
Jackson, Mississippi, United States
ACTIVE_NOT_RECRUITINGNew Mexico Orthopaedic Associates
Albuquerque, New Mexico, United States
RECRUITINGSyracuse Orthopaedic Specialists
DeWitt, New York, United States
RECRUITINGNYU
New York, New York, United States
RECRUITING...and 6 more locations
Oxford Knee Score (OKS)
A patient reported functional outcome score for knee arthroplasty. This score ranges from 0-48, with higher scores indicating a better outcome.
Time frame: 5 years
EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure
A questionnaire completed by the patient and assesses his/her general health status. This score ranges from -0.573 to 1, with higher recorded scores indicating better overall health.
Time frame: 5 years
Pain and Satisfaction Numeric Rating Scale (NRS)
Patients will rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"). Along with their pain rating, subjects will be asked to rate their current satisfaction with their surgery from "Very Dissatisfied" to "Very Satisfied".
Time frame: 5 years
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