The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.
The study design is a prospective, multicenter data collection model of the 510(k) cleared Persona Ti-Nidium 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. Investigators will collect clinical data for a required 10 years. Follow-up clinical visits include Early Post-op, 6 months, 1 year, 2, 3, 5, 7 and 10 years post-operatively. The objective of this study is to evaluate clinical performance, benefits and safety of the Persona Ti-Nidium implant in total knee arthroplasty. Specific assessments include: 1. Confirming the long-term safety, performance and clinical benefits of the Persona Ti-Nidium 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
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Primary Knee Total Arthroplasty
Denver Hip & Knee, Inc.
Parker, Colorado, United States
MedStar Health Research Institute
Hyattsville, Maryland, United States
Mississippi Sports Medicine and Orthopaedic Center
Jackson, Mississippi, United States
New Mexico Orthopaedic Associates
Albuquerque, New Mexico, United States
Duke University
Durham, North Carolina, United States
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States
Monument Health Rapid City Hospital, Inc.
Rapid City, South Dakota, United States
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: 10 years
Knee Society Score (KSS) Expectations (pre and post op)
This is a 3 question form regarding a patient's expectations of the total knee replacement. The pre-op form assesses the patient's expectations of the knee replacement, and the post-op form addresses how the replacement is meeting said expectations. The score ranges from 3-15, with higher scores indicating a better outcome.
Time frame: 10 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: 10 years
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