Clinical trial NCT03495232: Persona Cohort Nordic Multicenter Study
Official title: A Multicenter Prospective Cohort Study on Persona Total Knee System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Knee Arthropathy
Keywords: Total Knee Arthroplasty
Persona knee system
osteoarthrosis
Knee
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-04-11
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate patient reported outcome measures following primary total knee replacement using Persona Total Knee system
timeFrame: 2 years
Secondary outcomes:
measure: 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).
timeFrame: 2 years
measure: Evaluate patient quality of life following primary total knee replacement using Persona Total Knee system
timeFrame: 2 years
measure: Evaluate patient satisfaction following primary total knee replacement using Persona Total Knee system
timeFrame: 2 years
measure: Evaluate patient reported awareness of their knee following primary total knee replacement using Persona Total Knee system
timeFrame: 2 years
measure: Evaluate intraoperative and postoperative complications
timeFrame: 10 years
measure: Evaluate implant positioning following primary total knee replacement using Persona Total Knee system
timeFrame: 2 years
measure: Evaluate longer term survivorship following primary total knee replacement using Persona Total Knee system
timeFrame: 10 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Hvidovre
city: Saint-Grégoire
country: France
facility: Institute Locomoteur de L'Ouest
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Motala
country: Sweden
facility: Ortopedic Clinic, Motala Specialist Care Capio AB
Study officials:
affiliation: Copenhagen University Hospital, Hvidovre
name: Anders Troelsen, Prof
role: PRINCIPAL_INVESTIGATOR
References: