Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Persona Cohort Nordic Multicenter Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495232
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Tracking Information
First Submitted Date March 20, 2018
First Posted Date April 11, 2018
Last Update Posted Date September 29, 2020
Actual Study Start Date November 1, 2016
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 19, 2018)
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).
Original Primary Outcome Measures
 (submitted: April 10, 2018)
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)
Change History
Current Secondary Outcome Measures
 (submitted: April 19, 2018)
  • 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)
  • 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).
  • 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
  • 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)
  • Evaluate intraoperative and postoperative complications [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 10 years ]
    Survival of the implant through registries
Original Secondary Outcome Measures
 (submitted: April 10, 2018)
  • Evaluate patient reported physical activity level following primary total knee replacement using Persona Total Knee system [ Time Frame: 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 [ Time Frame: 2 years ]
    EuroQol Group (EQ5D) standardized measure of health status
  • Evaluate patient satisfaction following primary total knee replacement using Persona Total Knee system [ Time Frame: 2 years ]
    Anchoring questions
  • 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)
  • Evaluate intraoperative and postoperative complications [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 10 years ]
    Survival of the implant through registries
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Persona Cohort Nordic Multicenter Study
Official Title A Multicenter Prospective Cohort Study on Persona Total Knee System
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Knee Arthropathy
Intervention Device: Zimmer Biomet Persona total knee system
Product manufactured by Zimmer Biomet used to replace the knee joint.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 10, 2018)
700
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2032
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Wing To +441793607621 wing.to@zimmerbiomet.com
Contact: Emilie Rohmer +41588548210 Emilie.Rohmer@zimmerbiomet.com
Listed Location Countries Denmark,   Norway,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT03495232
Other Study ID Numbers K.CR.I.EU.15.13 Cohort
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Zimmer Biomet
Study Sponsor Zimmer Biomet
Collaborators Not Provided
Investigators
Principal Investigator: Anders Troelsen, Prof Copenhagen University Hospital, Hvidovre
PRS Account Zimmer Biomet
Verification Date September 2020