Persona Cohort Nordic Multicenter Study

Knee Arthropathy Clinical Trial

Official title:

A Multicenter Prospective Cohort Study on Persona Total Knee System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03495232
• Other study ID #: K.CR.I.EU.15.13 Cohort
• Status: Recruiting
• Start date: November 1, 2016
• Est. completion date: December 31, 2032

Study information

• Verified date: March 2024
• Source: Zimmer Biomet
• Contact: Chiara Griffoni
• Phone: +41795601628
• Email: chiara.griffoni[@]zimmerbiomet.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 31, 2032
• Est. primary completion date: April 7, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Knee Arthropathy

Intervention

Device:
• Zimmer Biomet Persona total knee system
Product manufactured by Zimmer Biomet used to replace the knee joint.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Denmark,  France,  Norway,  Sweden, 

Outcome

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