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

July 12, 2023 updated by: Smith & Nephew, Inc.

Safety and Performance of Journey II XR Total Knee System. A Retrospective, Multicenter Study

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
683

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Orthopedic Institute of the West
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Rush Copley Orthopaedics
    • Michigan
      • Port Huron, Michigan, United States, 48060
        • Jerry Orthopaedic Institute
    • Nevada
      • Reno, Nevada, United States, 89503
        • Reno Orthopedic Clinic
    • New Jersey
      • Somerset, New Jersey, United States, 08873
        • Orthopaedic Center of New Jersey
    • New York
      • New York, New York, United States, 10003
        • Hospital for Joint Diseases Orthopaedics Institute
    • Oregon
      • Oregon City, Oregon, United States, 97045
        • Regenerative Orthopedic Center (ROC)
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Texas
      • San Antonio, Texas, United States, 78258
        • San Antonio Orthopaedic Specialists
    • Virginia
      • Alexandria, Virginia, United States, 22306
        • Anderson Orthopaedic Clinic
    • West Virginia
      • Huntington, West Virginia, United States, 25702
        • Scott Orthopedic Center
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53142
        • Aurora Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Revision of one or more study device components
Time Frame: 12 weeks follow up
Measure of the number of revision cases
12 weeks follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health care utilization: Hospitalization
Time Frame: implantation through study completion, approximately 3 years
Length of hospital stay for primary (index) surgery
implantation through study completion, approximately 3 years
Adverse Events
Time Frame: 12 weeks follow up
All collected and reported AEs
12 weeks follow up
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)
Implantation through study completion, approximately 3 years
Health care utilization: Rehabilitation
Time Frame: Implantation through study completion, approximately 3 years
number of sessions and duration of rehabilitation in weeks
Implantation through study completion, approximately 3 years
Health care utilization: Outpatient visits
Time Frame: Implantation through study completion, approximately 3 years
Number and type of outpatient visits
Implantation through study completion, approximately 3 years
Health Care Utilization: Re-operations
Time Frame: Implantation through study completion, approximately 3 years
Number of re-operations and revisions
Implantation through study completion, approximately 3 years
Quality of Life: EQ-5D-3L
Time Frame: Implantation through study completion, approximately 3 years
EuroQol Five Dimensions Questionnaire
Implantation through study completion, approximately 3 years
Quality of Life: KSS
Time Frame: Implantation through study completion, approximately 3 years
2011 Knee Society Score
Implantation through study completion, approximately 3 years
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.
Implantation through study completion, approximately 3 years
Technical Difficulties Encountered During Device Implantation
Time Frame: Implantation through study completion, approximately 3 years
Number of technical difficulties encountered with the device
Implantation through study completion, approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Smith & Nephew, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nor Consult, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JIIXR.PMCF.2018.13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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