In this project the investigators wish to: Evaluate intra-operative and postop complications, longer term survivorship and patient reported outcome measures (PROMs) following primary total knee replacement using Persona Total Knee system. This project is carried out as prospective cohort study. Recruitment of participants to this project is expected to begin in October 2016 or as soon as permission from the Regional Ethics Committee and the local Data Protection Agency is obtained as required. A total of 700 participants (including 155 participants from a randomized controlled trial (RCT) investigating the Persona and the Nexgen total knee systems, which is separately submitted to the ethics committee) are to be included at several centers in the nordic region. Recruitment is expected complete after a period of 1,5 years per site. The patient follow-up visits are expected to be completed 2 years after recruitment of the last participant. Survivorship will be collected until 10 years after the recruitment of the last participant. Participants are seen on an outpatient basis at 3 months and 1 and 2 years postoperatively. After the 2 year follow-up visit the patients recruited in the Scandinavian sites will be followed for survivorship through the National Knee Arthroplasty Registries at 5, 7 and 10 years postoperatively. Since France does not have a national registry, the French site will also perform 5 year follow-up visits.
The investigators will retain the subject data sources, case report forms (CRFs) and electronic-CRFs in accordance with local laws and regulations. The enrollment is competitive between the participating centers. Project information and consent according to local requirements before surgery is completed. Surgery is performed as described in the manufacturer's surgical technique. A senior surgeon dedicated to total knee arthroplasty surgery will perform all operations with an assistant. Participants will receive standard pain treatment and rehabilitation until discharge.
Study Type
OBSERVATIONAL
Enrollment
700
Product manufactured by Zimmer Biomet used to replace the knee joint.
Copenhagen University Hospital, Hvidovre
Copenhagen, Denmark
Institute Locomoteur de L'Ouest
Saint-Grégoire, France
St Olavs Hospital
Trondheim, Norway
Ortopedic Clinic, Motala Specialist Care Capio AB
Motala, Sweden
Evaluate patient reported outcome measures following primary total knee replacement using Persona Total Knee system
Evaluate patient reported outcome measures following primary total knee replacement using Persona Total Knee system as measured by Oxford knee score (OKS); a 12-item patient-reported Patient Reported Outcomes specifically designed and developed to assess function and pain after total knee replacement surgery. Score ranging from 0 (most severe symptoms/problems) to 48 (least severe).
Time frame: 2 years
Evaluate patient reported physical activity level following primary total knee replacement using Persona Total Knee system. An 8-item patient-reported outcome. Score ranging from 0 (most severe symptoms/problems) to 32 (least severe).
Oxford knee score Activity \& Participation Questionnaire (OKS, APQ)
Time frame: 2 years
Evaluate patient quality of life following primary total knee replacement using Persona Total Knee system
EuroQol Group (EQ5D) standardized measure of health status. Measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Overall health status rated by the patient using the visual analogue scale (EQ-VAS).
Time frame: 2 years
Evaluate patient satisfaction following primary total knee replacement using Persona Total Knee system
Anchoring questions. Focusing on Patient perception of their knee and their satisfaction with the knee after their knee surgery
Time frame: 2 years
Evaluate patient reported awareness of their knee following primary total knee replacement using Persona Total Knee system
Forgotten Joint Score (FJS)
Time frame: 2 years
Evaluate intraoperative and postoperative complications
Register adverse events including intraoperative complications and revisions at any postoperative time point.
Time frame: 10 years
Evaluate implant positioning following primary total knee replacement using Persona Total Knee system
Measure radiolucency and osteolysis using conventional radiographs in anterior posterior (AP) and lateral views.
Time frame: 2 years
Evaluate longer term survivorship following primary total knee replacement using Persona Total Knee system
Survival of the implant through registries
Time frame: 10 years
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