NCT04821154

Persona Revision Knee System Outcomes

Clinical Investigation to Demonstrate Performance, Safety and Clinical Benefits of the Persona Revision Knee System

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 380 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate 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. This will be done using a multicenter, single-arm, consecutive series, retrospective cohort study with prospective follow-up.

Detailed description

Under study are the Persona® Revision Knee System (K181947 and K191625) implants and instrumentation, and any compatible devices being used in conjunction according to the Instructions for Use. This will be accomplished by retrospectively identifying patients who underwent primary or revision TKA with this system and inviting them to participate in prospective data collection at 1, 2, 3, 4, 5, 7, and 10 years postoperative follow-up. As the device was not available for commercial use until late 2019, the retrospective portion will involve those activities that occurred per standard of care for participants. The primary endpoint for this study will be performance assessed by improvement in the 1989 Knee Society Clinical Rating System (KS) objective knee score (KS-KS) from baseline to 2 years (as evaluated using the overall group mean showing at least the Minimal Clinically Important Difference (MCID) of 5.4 points). A maximum of 20 sites will contribute to this study. There will be a maximum of 380 patients enrolled in the study.

Conditions

• Arthroplasty Complications
• Infection
• Knee Disease
• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Persona Revision Knee System	Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.

Timeline

• Start date: 2021-06-14
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2021-03-29
• Last updated: 2025-10-24

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated device study