Persona Cohort Nordic Multicenter Study

NCT03495232 | Active Not Recruiting FDA Device

• 1 other identifier: K.CR.I.EU.15.13 Cohort
• Study Type: observational
• Target: 700
• Locations: 4 countries
• Sites: 4

Brief 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.

Conditions

Knee Arthropathy

Keywords

Total Knee Arthroplasty; Persona knee system; osteoarthrosis; Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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).

  2 years

• Evaluate patient quality of life following primary total knee replacement using Persona Total Knee system

  2 years

• Evaluate patient satisfaction following primary total knee replacement using Persona Total Knee system

  2 years

• Evaluate patient reported awareness of their knee following primary total knee replacement using Persona Total Knee system

  2 years

• Evaluate intraoperative and postoperative complications

  10 years

Interventions

Zimmer Biomet Persona total knee system DEVICE

Product manufactured by Zimmer Biomet used to replace the knee joint.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (4)

Copenhagen University Hospital, Hvidovre

Copenhagen, Denmark

Location

Institute Locomoteur de L'Ouest

Saint-Grégoire, 35760, France

Location

St Olavs Hospital

Trondheim, Norway

Location

Ortopedic Clinic, Motala Specialist Care Capio AB

Motala, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Anders Troelsen, Prof

  Copenhagen University Hospital, Hvidovre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 11, 2018
• Study Start: November 1, 2016
• Primary Completion (Estimated): April 7, 2029
• Study Completion (Estimated): December 31, 2032
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); DK (1); NO (1); SE (1)