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Safety and Performance of Journey II XR Total Knee System (JIIXR)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03798847
Recruitment Status : Completed
First Posted : January 10, 2019
Last Update Posted : September 28, 2021
Sponsor:
Collaborator:
Nor Consult, LLC
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Study Description
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Brief Summary:
The objective of this study is to estimate the safety and performance of Journey II XR TKS based on retrospective data.

Condition or disease Intervention/treatment
Journey II XR Total Knee System Device: Journey II XR TKA

Study Design
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Study Type : Observational
Actual Enrollment : 683 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Safety and Performance of Journey II XR Total Knee System. A Retrospective, Multicenter Study
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : September 10, 2020
Actual Study Completion Date : September 10, 2020
Groups and Cohorts
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Intervention Details:
  • Device: Journey II XR TKA
    Journey II XR Total Knee System

Outcome Measures
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Primary Outcome Measures :
  1. Revision of one or more study device components [ Time Frame: 12 weeks follow up ]
    Measure of the number of revision cases


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 12 weeks follow up ]
    All collected and reported AEs

  2. Health care utilization: Hospitalization [ Time Frame: implantation through study completion, approximately 3 years ]
    Length of hospital stay for primary (index) surgery

  3. Health care utilization: Hospitalization [ Time Frame: Implantation through study completion, approximately 3 years ]
    Hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery (number and length of stay)

  4. Health care utilization: Rehabilitation [ Time Frame: Implantation through study completion, approximately 3 years ]
    number of sessions and duration of rehabilitation in weeks

  5. Health care utilization: Outpatient visits [ Time Frame: Implantation through study completion, approximately 3 years ]
    Number and type of outpatient visits

  6. Health Care Utilization: Re-operations [ Time Frame: Implantation through study completion, approximately 3 years ]
    Number of re-operations and revisions

  7. Quality of Life: EQ-5D-3L [ Time Frame: Implantation through study completion, approximately 3 years ]
    EuroQol Five Dimensions Questionnaire

  8. Quality of Life: KSS [ Time Frame: Implantation through study completion, approximately 3 years ]
    2011 Knee Society Score

  9. Return to Work [ Time Frame: Implantation through study completion, approximately 3 years ]
    Changes in employment status will be recorded with the date on which the change occurred and the change status.

  10. Technical Difficulties Encountered During Device Implantation [ Time Frame: Implantation through study completion, approximately 3 years ]
    Number of technical difficulties encountered with the device


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR TKS for approved indication
Criteria

Inclusion Criteria:

  • Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR TKS for approved indication;
  • The TKA occurred at least 12 weeks prior to enrollment.

Exclusion Criteria:

- None

Contacts and Locations
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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): NCT03798847


Locations
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United States, Arizona
Orthopedic Institute of the West
Phoenix, Arizona, United States, 85054
United States, Illinois
Rush Copley Orthopaedics
Aurora, Illinois, United States, 60504
United States, Michigan
Jerry Orthopaedic Institute
Port Huron, Michigan, United States, 48060
United States, Nevada
Reno Orthopedic Clinic
Reno, Nevada, United States, 89503
United States, New Jersey
Orthopaedic Center of New Jersey
Somerset, New Jersey, United States, 08873
United States, New York
Hospital for Joint Diseases Orthopaedics Institute
New York, New York, United States, 10003
United States, Oregon
Regenerative Orthopedic Center (ROC)
Oregon City, Oregon, United States, 97045
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Texas
San Antonio Orthopaedic Specialists
San Antonio, Texas, United States, 78258
United States, Virginia
Anderson Orthopaedic Clinic
Alexandria, Virginia, United States, 22306
United States, West Virginia
Scott Orthopedic Center
Huntington, West Virginia, United States, 25702
United States, Wisconsin
Aurora Medical Center
Kenosha, Wisconsin, United States, 53142
Sponsors and Collaborators
Smith & Nephew, Inc.
Nor Consult, LLC
More Information
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Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT03798847    
Other Study ID Numbers: JIIXR.PMCF.2018.13
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
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: No
Keywords provided by Smith & Nephew, Inc.:
Journey II XR Total Knee System