Zimmer POLAR Persona - TKA (EMEA Study)

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.

Conditions

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

Interventions

DEVICE

Zimmer Persona Total Knee System

No Intervention

Sponsors & Collaborators

• Zimmer, GmbH

  lead INDUSTRY

Principal Investigators

• Martin Dominkus, MD · Orthopädisches Spital Speising, Wien, Austria

• Hendrik Verburg, MD · Stichting Research Orthopedie & Reinier de Graaf Groep, Delf, Netherlands

• Nicholas London, MD · Harrogate and District NHS, Harrogate, England

• Stéphane Boisgard, MD · CHU de Clermont-Ferrand, Clermont-Ferrand, France

• François Canovas, Prof · Hospital Lapeyronie, Montpellier

• Pere Torner, MD · Hospital Parc Tauli, Sabadell

• Jon Clarke, MD · Golden Jubilee National Hospital, Clydebank

• David Deehan, Prof · Freeman Hospital, Newcastle

• Karl Dieter Heller, Prof · HEH Braunschweig

• Fritz Thorey, Prof · Atos Klinik Heidelberg

• Fernando Martinez Delgado, MD · Hospital Miguel Servet Zaragoza

• Hermant Pandit, Prof · University of Leeds

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-18

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Austria
• France
• Germany
• Netherlands
• Spain
• United Kingdom

Study Locations