Persona Cohort Nordic Multicenter Study

A Multicenter Prospective Cohort Study on Persona Total Knee System

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Arthropathy
• Intervention / Treatment: Device: Zimmer Biomet Persona total knee system

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.

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Copenhagen University Hospital, Hvidovre
• France
  • Saint-Grégoire, France, 35760
    • Institute Locomoteur de L'Ouest
• Norway
  • Trondheim, Norway
    • St Olavs hospital
• Sweden
  • Motala, Sweden
    • Ortopedic Clinic, Motala Specialist Care Capio AB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any patient planned for primary total knee arthroplasty (TKA) on orthopedic surgeons' waiting list may be asked and selected for the study.

Description

Inclusion Criteria:

• Clinical and radiological osteoarthritis of the knee set to receive a primary unilateral total knee replacement

Exclusion Criteria:

• Patients who are unwilling or unable to give consent, or to comply with the follow-up program.
• Patients that meet any contraindications listed in the Instruction for Use

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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).	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	2 years
Evaluate patient reported awareness of their knee following primary total knee replacement using Persona Total Knee system	Forgotten Joint Score (FJS)	2 years
Evaluate intraoperative and postoperative complications	Register adverse events including intraoperative complications and revisions at any postoperative time point.	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.	2 years
Evaluate longer term survivorship following primary total knee replacement using Persona Total Knee system	Survival of the implant through registries	10 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Anders Troelsen, Prof, Copenhagen University Hospital, Hvidovre

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Estimated): April 7, 2029
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Knee; Total Knee Arthroplasty; osteoarthrosis; Persona knee system
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Enzyme Inhibitors; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Ulcer Agents; Histamine H2 Antagonists; Cimetidine
• Other Study ID Numbers: K.CR.I.EU.15.13 Cohort

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes