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Clinical Trial Summary

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


Clinical Trial Description

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, and 5 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 Design


Related Conditions & MeSH terms


NCT number NCT05787821
Study type Observational
Source Zimmer Biomet
Contact Tim Swanson
Phone 5745497606
Email tim.swanson@zimmerbiomet.com
Status Recruiting
Phase
Start date June 28, 2023
Completion date June 2031

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