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Safety and Performance of Journey II BCS Total Knee System Patient Reported Outcome Measures (JIIPROMS)

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ClinicalTrials.gov Identifier: NCT03903731
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Brief Summary:
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcome Measures.

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

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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcomes Measures
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Intervention Details:
  • Device: Journey II BCS Total Knee System
    Journey II BCS Total Knee System


Primary Outcome Measures :
  1. Revision of one or more study device components [ Time Frame: 12 Weeks ]
    We are measuring the number of revision cases


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: implantation through study completion, approximately 8 years ]
    Number of adverse events reported per ISO 14155 guidelines

  2. Health care utilization: Hospitalization [ Time Frame: implantation through study completion, approximately 8 years ]
    Length of hospital stay for primary (index) surgery

  3. Health care utilization: Hospitalization [ Time Frame: implantation through study completion, approximately 8 years ]
    Number of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery

  4. Health care utilization: Hospitalization [ Time Frame: implantation through study completion, approximately 8 years ]
    Length of stay for hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery

  5. Health care utilization: Rehabilitation [ Time Frame: implantation through study completion, approximately 8 years ]
    number of sessions and duration of rehabilitation in weeks

  6. Health care utilization: Outpatient visits [ Time Frame: implantation through study completion, approximately 8 years ]
    Number of outpatient visits

  7. Health care utilization: Outpatient visits [ Time Frame: implantation through study completion, approximately 8 years ]
    Type of outpatient visits

  8. Health Care Utilization: Re-operations [ Time Frame: implantation through study completion, approximately 8 years ]
    number of re-operations and revisions

  9. Patient reported outcome implantation [ Time Frame: implantation through study completion, approximately 8 years ]
    EQ-5D-3L - Change in quality of life from baseline to one year postoperatively by answering quality of life questions on a 1-5 scale with 1 representing "never" and 5 representing "always"

  10. Clinical outcomes [ Time Frame: implantation through study completion, approximately 8 years ]
    Knee Society Score - This validated tool combines an objective physician-derived component with a subjective subject-derived component. The objective section rates alignment, instability, joint motion and symptoms.

  11. Return to Work [ Time Frame: implantation through study completion, approximately 8 years ]
    Changes in employment status will be recorded with the date on which the change occurred and the change status.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who received the Journey II BCS Total Knee System
Criteria

Inclusion Criteria:

  • Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II BCS Total Knee System for approved indication;
  • The TKA occurred at least 12 weeks prior to enrollment
  • Subject records contain Patient Reported Outcome data obtained ≤3 months prior to as well as ≥6 months post-enrollment.

Exclusion Criteria:

  • Subject received the JOURNEY II BCS Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty

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): NCT03903731


Contacts
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Contact: Sandra Navarrete 512-895-1086 Sandra.navarrete@smith-nephew.com

Locations
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United States, Colorado
Department of Orthopaedics, University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact    303-724-2971    michael.dayton@ucdenver.edu   
Principal Investigator: Michael R. Dayton, MD         
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact    917-843-9854    maymand@hss.edu   
Principal Investigator: David J. Mayman, MD         
United States, Tennessee
Tennessee Orthopaedic Clinics Recruiting
Knoxville, Tennessee, United States, 37922
Contact    865-690-4861    cateshe@tocdocs.com   
Principal Investigator: Harold E. Cates, MD         
Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact       orthopedie.research@uzleuven.be   
Principal Investigator: Hilde Vandenneucker, MD         
New Zealand
Anglesea Clinic Orthopaedics Recruiting
Hamilton, New Zealand, 3204
Contact       peter@aco.org.nz   
Principal Investigator: Peter Black, MBBCh         
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
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Study Chair: Beate Hanson, MD, PhD Vice President, Clinical Strategy
Principal Investigator: Michael R. Dayton, MD Department of Orthopaedics, University of Colorado Denver
Principal Investigator: David J. Mayman, MD Hospital for Special Surgery, New York
Principal Investigator: Harold E. Cates, MD Tennessee Orthopaedic Clinics
Principal Investigator: Hilde Vandenneucker, MD UZ Leuven
Principal Investigator: Peter Black, MBBCh Anglesea Clinic Orthopaedics

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Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT03903731     History of Changes
Other Study ID Numbers: 16-4049-08B
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 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: No