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Register:	ClinicalTrials.gov
Last refreshed on:	18 March 2024
Main ID:	NCT03495232
Date of registration:	20/03/2018
Prospective Registration:	No
Primary sponsor:	Zimmer Biomet
Public title:	Persona Cohort Nordic Multicenter Study
Scientific title:	A Multicenter Prospective Cohort Study on Persona Total Knee System
Date of first enrolment:	November 1, 2016
Target sample size:	700
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT03495232
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Denmark	France	Norway	Sweden

Contacts

Name:	Chiara Griffoni
Address:
Telephone:	+41795601628
Email:	chiara.griffoni@zimmerbiomet.com
Affiliation:

Name:	Anders Troelsen, Prof
Address:
Telephone:
Email:
Affiliation:

Name:	Anders Troelsen, Prof
Address:
Telephone:
Email:
Affiliation:	Copenhagen University Hospital, Hvidovre

Key inclusion & exclusion 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

Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Knee Arthropathy

Intervention(s)

Device: Zimmer Biomet Persona total knee system

Primary Outcome(s)

Evaluate patient reported outcome measures following primary total knee replacement using Persona Total Knee system [Time Frame: 2 years]

Secondary Outcome(s)

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). [Time Frame: 2 years]

Evaluate patient quality of life following primary total knee replacement using Persona Total Knee system [Time Frame: 2 years]

Evaluate implant positioning following primary total knee replacement using Persona Total Knee system [Time Frame: 2 years]

Evaluate intraoperative and postoperative complications [Time Frame: 10 years]

Evaluate longer term survivorship following primary total knee replacement using Persona Total Knee system [Time Frame: 10 years]

Evaluate patient reported awareness of their knee following primary total knee replacement using Persona Total Knee system [Time Frame: 2 years]

Evaluate patient satisfaction following primary total knee replacement using Persona Total Knee system [Time Frame: 2 years]

Secondary ID(s)

K.CR.I.EU.15.13 Cohort

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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