Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
700 participants
OBSERVATIONAL
2016-11-01
2032-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Zimmer Biomet Persona total knee system
Product manufactured by Zimmer Biomet used to replace the knee joint.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients that meet any contraindications listed in the Instruction for Use
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Anders Troelsen, Prof
Role: PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital, Hvidovre
Locations
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Copenhagen University Hospital, Hvidovre
Copenhagen, , Denmark
Institute Locomoteur de L'Ouest
Saint-Grégoire, , France
St Olavs Hospital
Trondheim, , Norway
Ortopedic Clinic, Motala Specialist Care Capio AB
Motala, , Sweden
Countries
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Other Identifiers
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K.CR.I.EU.15.13 Cohort
Identifier Type: -
Identifier Source: org_study_id