NCT03495232

Persona Cohort Nordic Multicenter Study

A Multicenter Prospective Cohort Study on Persona Total Knee System

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 700 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Knee Arthropathy

Interventions

Type	Name	Description
DEVICE	Zimmer Biomet Persona total knee system	Product manufactured by Zimmer Biomet used to replace the knee joint.

Timeline

• Start date: 2016-11-01
• Primary completion: 2029-04-07
• Completion: 2032-12-31
• First posted: 2018-04-11
• Last updated: 2025-12-18

Locations

4 sites across 4 countries: Denmark, France, Norway, Sweden

Regulatory

• FDA-regulated device study