Persona Cohort Nordic Multicenter Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03495232
Study type	Observational
Source	Zimmer Biomet
Contact	Chiara Griffoni
Phone	+41795601628
Email	chiara.griffoni@zimmerbiomet.com
Status	Recruiting
Phase
Start date	November 1, 2016
Completion date	December 31, 2032

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.