Persona Cohort Nordic Multicenter Study

Sponsor

Zimmer Biomet (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03495232

Collaborator

(none)

700

Enrollment

Locations

194

Anticipated Duration (Months)

233.3

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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 will be followed for survivorship through the National Knee Arthroplasty Registries at 5, 7 and 10 years postoperatively.

Condition or Disease	Intervention/Treatment	Phase
Knee Arthropathy	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 Design

Study Type:

Observational

Anticipated Enrollment :

700 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Multicenter Prospective Cohort Study on Persona Total Knee System

Actual Study Start Date :

Nov 1, 2016

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2032

Outcome Measures

Primary Outcome Measures

Evaluate patient reported outcome measures following primary total knee replacement using Persona Total Knee system [2 years]
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).

Secondary Outcome Measures

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]
Oxford knee score Activity & Participation Questionnaire (OKS, APQ)
Evaluate patient quality of life following primary total knee replacement using Persona Total Knee system [2 years]
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).
Evaluate patient satisfaction following primary total knee replacement using Persona Total Knee system [2 years]
Anchoring questions. Focusing on Patient perception of their knee and their satisfaction with the knee after their knee surgery
Evaluate patient reported awareness of their knee following primary total knee replacement using Persona Total Knee system [2 years]
Forgotten Joint Score (FJS)
Evaluate intraoperative and postoperative complications [10 years]
Register adverse events including intraoperative complications and revisions at any postoperative time point.
Evaluate implant positioning following primary total knee replacement using Persona Total Knee system [2 years]
Measure radiolucency and osteolysis using conventional radiographs in anterior posterior (AP) and lateral views.
Evaluate longer term survivorship following primary total knee replacement using Persona Total Knee system [10 years]
Survival of the implant through registries

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	Country
1	Copenhagen University Hospital, Hvidovre	Copenhagen	Denmark
2	St Olavs Hospital	Trondheim	Norway
3	Ortopedic Clinic, Motala Specialist Care Capio AB	Motala	Sweden