NCT02337244

Zimmer POLAR Persona - TKA (EMEA Study)

Persona Outcomes Led Assessment Research in Total Knee Arthroplasty (POLAR - TKA)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 777 (actual)
• Sponsor: Zimmer, GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona knee implants used in primary total knee arthroplasty. The assessment will include: 1. Implant survivorship based on removal of a study device. 2. Safety based on incidence and frequency of adverse events. 3. Clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship.

Detailed description

This is a prospective, multicenter, non-controlled study of the commercially available Persona knee implants. The study will require each site to obtain Ethics approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process. Study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 5 days to 6 weeks, 3 to 6 months, 1 year, 2, 3, 4, and 5 years after implantation. The hospital CHU Clermont-Ferrand, France with PI Prof. Boisgard will conduct additional 7 (voluntary) and 10 years (standard of care) follow-up visits.

Conditions

• Severe Knee Pain
• Severe Knee Disability
• Osteoarthritis
• Rheumatoid Arthritis
• Traumatic Arthritis
• Polyarthritis

Interventions

Type	Name	Description
DEVICE	Zimmer Persona Total Knee System	No Intervention

Timeline

• Start date: 2013-11-18
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2015-01-13
• Last updated: 2025-11-25

Locations

12 sites across 6 countries: Austria, France, Germany, Netherlands, Spain, United Kingdom