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Persona Cohort Nordic Multicenter Study

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ClinicalTrials.gov Identifier: NCT03495232
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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
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.

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Study Type : Observational
Estimated 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 : November 1, 2016
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement


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


Primary Outcome Measures :
  1. Evaluate patient reported outcome measures following primary total knee replacement using Persona Total Knee system [ Time Frame: 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 :
  1. 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 ]
    Oxford knee score Activity & Participation Questionnaire (OKS, APQ)

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

  3. Evaluate patient satisfaction following primary total knee replacement using Persona Total Knee system [ Time Frame: 2 years ]
    Anchoring questions. Focusing on Patient perception of their knee and their satisfaction with the knee after their knee surgery

  4. Evaluate patient reported awareness of their knee following primary total knee replacement using Persona Total Knee system [ Time Frame: 2 years ]
    Forgotten Joint Score (FJS)

  5. Evaluate intraoperative and postoperative complications [ Time Frame: 10 years ]
    Register adverse events including intraoperative complications and revisions at any postoperative time point.

  6. Evaluate implant positioning following primary total knee replacement using Persona Total Knee system [ Time Frame: 2 years ]
    Measure radiolucency and osteolysis using conventional radiographs in anterior posterior (AP) and lateral views.

  7. Evaluate longer term survivorship following primary total knee replacement using Persona Total Knee system [ Time Frame: 10 years ]
    Survival of the implant through registries



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495232


Contacts
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Contact: Trine Blædel, PhD 0045 23221489 Trine.Blaedel@zimmerbiomet.com
Contact: Ville Pitkänen 00358505213929 ville.pitkanen@zimmerbiomet.com

Locations
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Denmark
Copenhagen University Hospital, Hvidovre Recruiting
Copenhagen, Denmark
Contact: Anders Troelsen, Prof         
Norway
St Olavs Hospital Not yet recruiting
Trondheim, Norway
Contact: Otto S Husby, MD         
Contact: Vigdis S Husby, Phd         
Sweden
Ortopedic Clinic, Motala Specialist Care Aleris AB Recruiting
Motala, Sweden
Contact: Hakan Ledin, MD         
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Principal Investigator: Anders Troelsen, Prof Copenhagen University Hospital, Hvidovre
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03495232    
Other Study ID Numbers: K.CR.I.EU.15.13 Cohort
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Zimmer Biomet:
Total Knee Arthroplasty
Persona knee system
osteoarthrosis
Knee
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Cimetidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors