Persona Cohort Nordic Multicenter Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03495232|
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : June 26, 2019
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 will be followed for survivorship through the National Knee Arthroplasty Registries at 5, 7 and 10 years postoperatively.
|Condition or disease||Intervention/treatment|
|Knee Arthropathy||Device: Zimmer Biomet Persona total knee system|
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|
|Estimated Enrollment :||700 participants|
|Official Title:||A Multicenter Prospective Cohort Study on Persona Total Knee System|
|Actual Study Start Date :||November 1, 2016|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2032|
- Device: Zimmer Biomet Persona total knee system
Product manufactured by Zimmer Biomet used to replace the knee joint.
- Evaluate patient reported outcome measures following primary total knee replacement using Persona Total Knee system [ Time Frame: 2 years ]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).
- 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). [ Time Frame: 2 years ]Oxford knee score Activity & Participation Questionnaire (OKS, APQ)
- Evaluate patient quality of life following primary total knee replacement using Persona Total Knee system [ Time Frame: 2 years ]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).
- Evaluate patient satisfaction following primary total knee replacement using Persona Total Knee system [ Time Frame: 2 years ]Anchoring questions. Focusing on Patient perception of their knee and their satisfaction with the knee after their knee surgery
- Evaluate patient reported awareness of their knee following primary total knee replacement using Persona Total Knee system [ Time Frame: 2 years ]Forgotten Joint Score (FJS)
- Evaluate intraoperative and postoperative complications [ Time Frame: 10 years ]Register adverse events including intraoperative complications and revisions at any postoperative time point.
- Evaluate implant positioning following primary total knee replacement using Persona Total Knee system [ Time Frame: 2 years ]Measure radiolucency and osteolysis using conventional radiographs in anterior posterior (AP) and lateral views.
- Evaluate longer term survivorship following primary total knee replacement using Persona Total Knee system [ Time Frame: 10 years ]Survival of the implant through registries
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495232
|Contact: Trine Blædel, PhD||0045 23221489||Trine.Blaedel@zimmerbiomet.com|
|Contact: Ville Pitkänenemail@example.com|
|Copenhagen University Hospital, Hvidovre||Recruiting|
|Contact: Anders Troelsen, Prof|
|St Olavs Hospital||Not yet recruiting|
|Contact: Otto S Husby, MD|
|Contact: Vigdis S Husby, Phd|
|Ortopedic Clinic, Motala Specialist Care Aleris AB||Recruiting|
|Contact: Hakan Ledin, MD|
|Principal Investigator:||Anders Troelsen, Prof||Copenhagen University Hospital, Hvidovre|