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JOURNEY II XR Safety and Effectiveness PMCF

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ClinicalTrials.gov Identifier: NCT03136887
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Rheumatoid Vasculitis With Rheumatoid Arthritis of Knee Unilateral Post-Traumatic Osteoarthritis of Knee Knee Osteoarthritis Degenerative Arthritis Peripheral Joint Failed Osteotomies Failed Unicompartmental Replacement Device: JOURNEY II XR Total Knee System

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.

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Study Type : Observational
Estimated Enrollment : 174 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicenter, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of the JOURNEY™ II XR Total Knee System
Actual Study Start Date : July 28, 2017
Estimated Primary Completion Date : April 2029
Estimated Study Completion Date : April 2029

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Implant survival rate [ Time Frame: 10 years ]
    Did knee survive with no revision through 10 years


Secondary Outcome Measures :
  1. Knee function [ Time Frame: 10 years ]
    Lateral Step-Up Test

  2. Quality of Life - EQ-5D - 3L [ Time Frame: 10 years ]
    Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire

  3. Quality of Life - FJS [ Time Frame: 10 years ]
    Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire

  4. Quality of Life - KOOS [ Time Frame: 10 years ]
    Patient Reported Outcomes using Knee Injury and Osteoarthritic Outcome Scores (KOOS) questionnaire

  5. Quality of Life - ABC scale [ Time Frame: 10 years ]
    Patient Reported Outcomes using Activities-specific Balance Confidence (ABC) questionnaire

  6. Quality of Life - SAPSS [ Time Frame: 10 years ]
    Patient Reported Outcomes using Self-Administered Patient Satisfaction Score (SAPSS) questionnaire

  7. Physiotherapy (PT) utilization - No. of visits [ Time Frame: 6 Months Post-operatively ]
    Number of PT visits required up to 6 months after surgery

  8. 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

  9. Radiographic outcomes [ Time Frame: 10 years ]
    X-rays of index joint

  10. Adverse Events (AEs) [ Time Frame: 10 years ]
    All AEs will be collected and reported



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be selected from their orthopedic surgeons practice.
Criteria

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.).

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): NCT03136887


Contacts
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Contact: Stacy Leake-Gardner 901-399-5893 Stacy.Leake-Gardner@smith-nephew.com
Contact: Shirley Mak-Parisi 978-749-1459 shirley.mak-parisi@smith-nephew.com

Locations
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United States, California
Loma Linda University Dept. of Orthopaedic Surgery Recruiting
Loma Linda, California, United States, 92354
Contact: Elizabeth Clarke    909-558-5592    eaclarke@llu.edu   
Principal Investigator: Nirav Amin, MD         
United States, Florida
Holy Cross Orthopedic Institute Recruiting
Fort Lauderdale, Florida, United States, 33334
Contact: Shanell Disla    954-229-8682    shanell.disla@holy-cross.com   
Principal Investigator: Martin Roche, MD         
United States, Illinois
Castle Orthopaedics & Sports Medicine, S.C. Recruiting
Aurora, Illinois, United States, 60504
Contact: Rob Johnson, PA    630-978-3800    robert.johnson@rushcopley.com   
Principal Investigator: Mark Schinsky, MD         
Midwest Orthopaedics at Rush Recruiting
Chicago, Illinois, United States, 60612
Contact: Katherine (Kate) Braunsky, RN    312-432-2429    katherine.braunsky@rushortho.com   
Principal Investigator: Tad Gerlinger, MD         
United States, Maryland
Anne Arundel Medical Center Recruiting
Annapolis, Maryland, United States, 21401
Contact: Marcia Fowler    443-481-5757    mfowler3@aahs.org   
Principal Investigator: James MacDonald, MD         
United States, Nevada
Reno Orthopaedic Center Recruiting
Reno, Nevada, United States, 89503
Contact: Gayle Blevins, CCRC    775-788-5190      
Principal Investigator: Mihael Ries, MD         
Principal Investigator: Jackson Jones, MD         
United States, New Jersey
Mercer Bucks Orthopaedics Terminated
Hamilton, New Jersey, United States, 08691
United States, New York
NYU Hospital for Joint Diseases / NYU Langone Medical Center Recruiting
New York, New York, United States, 10003
Contact: Ariel Aponte, CCRC    212-460-0176    ariel.aponte@nyumc.org   
Contact: Ivelisse Rodriguez Pagan    212-598-2311    Ivelisse.pagan@nyumc.org   
Principal Investigator: Ran Schwarzkopf, MD         
Sub-Investigator: Ivan F Madrid, MD         
Center for Hip & Knee Replacement Not yet recruiting
New York, New York, United States, 10032
Contact: Emma Jennings    212-305-8193    ej2290@cumc.columbia.edu   
Principal Investigator: Herbert J. Cooper, MD         
United States, Ohio
The Lindner Research Center at the Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Sandra Foglesong    513-585-1699    sandra.foglesong@thechristhospital.com   
Principal Investigator: Michael Swank, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Adam Rosencrans    503-494-2345    rosencad@ohs.edu   
Principal Investigator: Tom Huff, MD         
United States, Washington
Providence Regional Medical Center Everett Recruiting
Everett, Washington, United States, 98201
Contact: Dean Rocco, UK    425-261-3499    Dean.Rocco@providence.org   
Principal Investigator: William (Bill) Huang, MD         
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
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Study Chair: Beate Hanson, VP, PhD Vice President, Global Clinical Strategy

Publications:

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Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT03136887     History of Changes
Other Study ID Numbers: 16-4049-06
U1111-1191-7751 ( Other Identifier: WHO )
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Vasculitis
Rheumatoid Vasculitis
Systemic Vasculitis
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases