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Clinical Trial Summary

The main objective of this study is to evaluate the safety, performance, and clinical benefits of the Persona Keel cementless and cemented knee.


Clinical Trial Description

This is a prospective, multi-center, randomized controlled trial to demonstrate safety, performance, and clinical benefits of the Persona Keel CR Knee System and instrumentation. Participants that meet eligibility criteria and sign an institutional review board (IRB) Informed Consent form will be randomized to receive either the Persona OsseoTi Keel Cementless System or the Persona Keel Cemented System. Participants will be blinded to which arm they have been randomized to until after surgery. All study participants will undergo preoperative clinical evaluations prior to their total knee arthroplasty. Investigators will collect clinical data for up to 5 years; follow-up clinic visits will occur at 3 months, 1 year, 2 years, and 5 years after surgery. A maximum of 10 sites will contribute to this study. There will be a maximum of 300 participants enrolled (150 Cementless, 150 Cemented). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05630053
Study type Interventional
Source Zimmer Biomet
Contact Brittany Nierste
Phone 574-527-3850
Email brittany.nierste@zimmerbiomet.com
Status Recruiting
Phase N/A
Start date July 25, 2023
Completion date December 2032

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