Zimmer POLAR Persona - TKA (EMEA Study)

Rheumatoid Arthritis Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT02337244
• Study type: Observational
• Source: Zimmer Biomet
• Status: Active, not recruiting
• Start date: November 18, 2013
• Completion date: December 2027