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.
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.
Study Type
OBSERVATIONAL
Enrollment
777
No Intervention
Orthopädisches Spital Speising
Vienna, Austria
CHU de Clermont-Ferrand
Clermont-Ferrand, France
Centre Hospitalier régional Universitaire de Montpellier
Montpellier, France
HEH Braunschweig
Braunschweig, Germany
Atos Klinik Heidelberg
Heidelberg, Germany
Stichting Research Orthopedie & Reinier de Graaf Groep
Delft, Netherlands
Hospital Parc Tauli
Sabadell, Spain
Hospital Miguel Servet
Zaragoza, Spain
University of Leeds
Leeds, Leeds/UK, United Kingdom
Golden Jubilee National Hospital
Clydebank, United Kingdom
...and 2 more locations
Kaplan-Meier Implant Survivorship
Kaplan-Meier survivorship at 5 years with revision of any implant component, for any reason, as endpoint.
Time frame: 5 years
'Knee injury and Osteoarthritis Outcome Score' (KOOS) subscale scores.
The scores related to the five KOOS subscales calculated at different time points until 5 years.
Time frame: 5 years
'Forgotten Joint Score' (FJS-12)
The score related to the FJS-12 patient-reported questionaire calculated at different time points until 5 years.
Time frame: 5 years
Oxford Knee Score (OKS)
The score related to the OKS patient-reported questionaire calculated at different time points until 5 years.
Time frame: 5 years
EuroQol (EQ)-5D-3L score and EQ 'Visual Analog Scale' (VAS)
The scores related to the EQ-5D-3L questionnaire and the EQ-VAS calculated at different time points until 5 years.
Time frame: 5 years
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