JOURNEY II XR Safety and Effectiveness PMCF

August 9, 2024 updated by: Smith & Nephew, Inc.

A Prospective, Multicenter, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of the JOURNEY™ II XR Total Knee System

This study was designed to demonstrate the safety and performance of the JOURNEY II XR total knee system by evaluating implant survival rates at 10 years using Kaplan-Meier analysis. All participants will be implanted with the JOURNEY II XR total knee system.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.

Detailed Description

Total knee arthroplasty (TKA) is considered the most beneficial and cost-effective treatment for end-stage knee arthritis and is the most frequently performed joint replacement surgery. TKA is also indicated for earlier osteoarthritis (OA) interventions, such as osteotomy or unicompartmental replacement, when additional treatment is warranted. One device option available once the decision is made to perform TKA is the JOURNEY II XR Total Knee System. The JOURNEY II XR Total Knee System is designed to be a more "natural feeling" total knee replacement. The goal of the JOURNEY II XR is to enable a higher level of function after total knee replacement by relieving pain and restoring the ability to participate in active lifestyles. The main aim of this study is to generate long-term safety and performance data for the JOURNEY™ II XR Total Knee System. Effectiveness information such as short- and long-term function, subject satisfaction, and quality of life will also be measured.

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.
176

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
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Dept. of Orthopaedic Surgery
    • Florida
      • Fort Lauderdale, Florida, United States, 33334
        • Holy Cross Orthopedic Institute
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Castle Orthopaedics & Sports Medicine, S.C.
      • Chicago, Illinois, United States, 60612
        • Midwest Orthopaedics at Rush
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Medical Center
    • Michigan
      • Rochester, Michigan, United States, 48307
        • DeClaire LaMacchia Orthopaedic Institute
    • Nevada
      • Reno, Nevada, United States, 89503
        • Reno Orthopaedic Center
    • New Jersey
      • Hamilton, New Jersey, United States, 08691
        • Mercer Bucks Orthopaedics
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery
      • New York, New York, United States, 10003
        • NYU Hospital for Joint Diseases / NYU Langone Medical Center
      • New York, New York, United States, 10032
        • Columbia University Center for Hip & Knee Replacement
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Research Center at The Christ Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Regional Medical Center Everett

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

22 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients will be selected from their orthopedic surgeons practice.

Description

Inclusion Criteria:

  1. require TKA due to rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis, failed osteotomies, or failed unicompartmental replacement
  2. have all cruciate and collateral ligaments intact in the index joint
  3. adult patients that in the judgement of the Investigator are skeletally mature
  4. be willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires
  5. consent to participate in the study by signing the IRB/EC approved informed consent form

Exclusion Criteria:

  1. have any of the following conditions in the index joint:

    • Intra-articular corticosteroid therapy (or any other intra-articular therapy) in the study knee within 3 months of study enrollment
    • Significant varus or valgus deformities (>15º)
    • Incomplete or insufficient tissue surrounding the knee
    • Collateral ligament insufficiency
    • Inadequate bone stock to support the device (e.g., severe osteopenia/osteoporosis) or will require use of femoral and tibial stems
    • History of prior TKA

  2. have any of the following conditions in the contralateral joint:

    • a previous TKA as a revision for a failed total or unicondylar knee arthroplasty
    • a primary TKA or unicondylar knee arthroplasty that is not fully healed and well-functioning as determined by the Investigator

  3. have any of the following conditions of the hip:

    • a previous contralateral or ipsilateral revision hip arthroplasty
    • ipsilateral hip arthritis resulting in flexion contracture
    • previously received an ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty that is not fully healed and well-functioning as determined by the Investigator
  4. have a diagnosis of an immunosuppressive disorder
  5. have an active infection, treated or untreated, systemic or at the site of the planned surgery
  6. have conditions that may interfere with the TKA survival or outcome, including but not limited to: Paget's disease, Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease
  7. have a BMI > 40
  8. be facing current or impending incarceration
  9. have a known allergy to study device or one or more of its components
  10. be pregnant or have plans to become pregnant during the course of the study
  11. have, in the opinion of the Investigator, an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse
  12. be enrolled in another drug, biologic, or device study within 30 days of screening
  13. be known to be at risk for lost to follow-up or failure to return for scheduled visits
  14. during the surgery, have a cruciate ligament tibial bone island that is secured with any fixative device (e.g. screw, plate, etc.).

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
JOURNEY II XR TKA
This is a single arm study, all subjects will receive JOURNEY II XR TKA
Device: JOURNEY II XR Total Knee System
JOURNEY II XR Total Knee System

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
Implant survival rate
Time Frame: 10 years
Did knee survive with no revision through 10 years
10 years

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
Knee function
Time Frame: 10 years
Lateral Step-Up Test
10 years
Quality of Life - EQ-5D - 3L
Time Frame: 10 years
Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire
10 years
Quality of Life - FJS
Time Frame: 10 years
Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire
10 years
Quality of Life - KOOS
Time Frame: 10 years
Patient Reported Outcomes using Knee Injury and Osteoarthritic Outcome Scores (KOOS) questionnaire
10 years
Quality of Life - ABC scale
Time Frame: 10 years
Patient Reported Outcomes using Activities-specific Balance Confidence (ABC) questionnaire
10 years
Quality of Life - SAPSS
Time Frame: 10 years
Patient Reported Outcomes using Self-Administered Patient Satisfaction Score (SAPSS) questionnaire
10 years
Physiotherapy (PT) utilization - No. of visits
Time Frame: 6 Months Post-operatively
Number of PT visits required up to 6 months after surgery
6 Months Post-operatively
Physiotherapy (PT) utilization - Period of visits
Time Frame: 6 Months Post-operatively
Time period during which PT appointments are required up to 6 months after surgery
6 Months Post-operatively
Radiographic outcomes
Time Frame: 10 years
X-rays of index joint
10 years
Adverse Events (AEs)
Time Frame: 10 years
All AEs will be collected and reported
10 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.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Stacy Leake-Gardner, Smith & Nephew, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
July 28, 2017

Primary Completion (Estimated)

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.
April 1, 2029

Study Completion (Estimated)

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.
April 1, 2029

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).
January 25, 2017

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.
April 27, 2017

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.
May 2, 2017

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.
August 12, 2024

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.
August 9, 2024

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.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 16-4049-06
  • U1111-1191-7751 (Other Identifier: WHO)

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

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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