Zimmer POLAR Persona - TKA (EMEA Study)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Osteoarthritis
- Polyarthritis
- Rheumatoid Arthritis
- Severe Knee Disability
- Severe Knee Pain
- Traumatic Arthritis
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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 subj...
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.
Tracking Information
- NCT #
- NCT02337244
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Martin Dominkus, MD Orthopädisches Spital Speising, Wien, Austria Principal Investigator: Hendrik Verburg, MD Stichting Research Orthopedie & Reinier de Graaf Groep, Delf, Netherlands Principal Investigator: Nicholas London, MD Harrogate and District NHS, Harrogate, England Principal Investigator: Stéphane Boisgard, MD CHU de Clermont-Ferrand, Clermont-Ferrand, France Principal Investigator: François Canovas, Prof Hospital Lapeyronie, Montpellier Principal Investigator: Pere Torner, MD Hospital Parc Tauli, Sabadell Principal Investigator: Jon Clarke, MD Golden Jubilee National Hospital, Clydebank Principal Investigator: David Deehan, Prof Freeman Hospital, Newcastle Principal Investigator: Karl Dieter Heller, Prof HEH Braunschweig Principal Investigator: Fritz Thorey, Prof Atos Klinik Heidelberg Principal Investigator: Fernando Martinez Delgado, MD Hospital Miguel Servet Zaragoza Principal Investigator: Hermant Pandit, Prof University of Leeds
Get Well Soon