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Safety and Performance of the Journey™ II UNI Unicompartmental Knee System (JII-Uni)

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ClinicalTrials.gov Identifier: NCT03768128
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Brief Summary:
This clinical study will evaluate the early to midterm safety and performance of the JOURNEY™ II UNI UKS in patients with non-inflammatory degenerative joint disease of the knee requiring lateral or medial knee compartment replacement. Clinical, radiographic, health economic and safety outcomes will be evaluated.

Condition or disease Intervention/treatment
Non-inflammatory Degenerative Joint Disease (NIDJD) of the Knee Device: Journey™ II UNI Unicompartmental Knee System

Detailed Description:
To assess the safety and performance of the JOURNEY™ II UNI UKS in patients with unicompartmental degeneration of the knee by demonstrating non-inferiority of the cumulative percent implant survival in subjects with the JOURNEY™ II UNI UKS implanted, compared to a literature reference rate of 91.7% (AOA annual report 2015)12 at 5 years.

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Study Type : Observational
Estimated Enrollment : 147 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Prospective, Multicenter Post-Market Clinical Follow-up Study to Evaluate the Safety and Performance of the Journey™ II UNI Unicompartmental Knee System
Actual Study Start Date : August 10, 2018
Estimated Primary Completion Date : May 1, 2025
Estimated Study Completion Date : May 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders


Intervention Details:
  • Device: Journey™ II UNI Unicompartmental Knee System

    Journey™ II UNI UKS is a CE Marked medical device. The device has been designed to treat both medial and lateral unicompartmental disease.

    It is a comprehensive system designed to allow surgeons to perform UKA. It is comprised of the following anatomic components: Oxidized zirconium femoral components Titanium tibial components with a grit-blasted surface Polyethylene tibial insert components The device is asymmetric and is available in oxidized zirconium to reduce wear and increase implant longevity.



Primary Outcome Measures :
  1. Implant survival 5 years postoperatively [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Device-related adverse events [ Time Frame: 5 year ]
    All AEs will be collected and reported

  2. Radiographic assessments [ Time Frame: 5 year ]
    To assess changes in implant fixation and bone integrity, an evaluation will be performed based upon comparison of Antero posterior and Lateral radiographs over multiple time-points. Radiographs will be also evaluated for radiolucencies, osteolysis, implant positioning, implant migration, implant loosening, periprosthetic fracture, wear of the articulating surfaces of replacement components



Information from the National Library of Medicine

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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
JOURNEY™ II UNI Unicompartmental Knee System (UKS) in patients with non-inflammatory degenerative joint disease (NIDJD) of the knee requiring either medial or lateral compartment knee replacement.
Criteria

Inclusion Criteria:

  • Subjects must meet all of the following criteria for inclusion in the study.

    1. Unicompartmental, NIDJD, including OA, traumatic arthritis, or avascular necrosis.
    2. Eighteen (18) years of age or older at the time of surgery.
    3. Skeletally mature in the judgement of the PI.
    4. Has met an acceptable preoperative medical clearance and is free of (or acceptably managed) cardiac, pulmonary, hematological, infection, or other conditions that would pose an excessive operative risk.
    5. Willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires.
    6. Consented to participate in the study by signing the EC-approved ICF.

      Exclusion Criteria:

  • Subjects meeting any of the following criteria must be excluded from participation in the study.

    1. Correction of functional deformity.
    2. Revision procedures where other treatments or devices have failed.
    3. Treatment of fractures that are unmanageable using other techniques.
    4. Inadequate bone stock to support the device which would make the procedure unjustifiable, including but not limited to severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia.
    5. Body Mass Index (BMI) > 40.
    6. Collateral ligament insufficiency.
    7. Active infection, treated or untreated, systemic or at the site of the planned surgery or previous intra-articular infections.
    8. Incomplete or deficient soft tissue surrounding the knee.
    9. Conditions that may interfere with the UKA survival or outcome, including but not limited to Paget's disease, Charcot disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease.
    10. Diagnosis of an immunosuppressive disorder.
    11. Known allergy to study device or one or more of its components.
    12. Pregnant or planning to become pregnant during the course of the study.
    13. Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation

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): NCT03768128


Contacts
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Contact: Marie-Christine Mallaroni, CSM +33 (0)6 77 64 03 41 MarieChristine.MALLARONI@smith-nephew.com

Locations
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United States, Illinois
Midwest Ortho at Rush Not yet recruiting
Chicago, Illinois, United States, 60612
Contact    312-432-2429    tad.gerlinger@rushortho.com   
Principal Investigator: Tad Gerlinger, MD         
Italy
Poliambulanza Institute Hospital Foundation Not yet recruiting
Brescia, Italy, 25124
Contact    0303515718    dot.segreteria@poliambulanza.it   
Principal Investigator: Flavio Terragnoli         
Istituto Clinico Villa Aprica Not yet recruiting
Como, Italy, 22100
Contact    +39 335269769    info@corradobait.com   
Principal Investigator: Corrado Bait         
Capitanio Hospital Not yet recruiting
Milano, Italy, 20122
Contact    +39 338 280 38 79    info@augustopalermo.com   
Principal Investigator: Augusto Palermo         
University Hospital of Modena Not yet recruiting
Modena, Italy, 41125
Contact       ensiniandrea@gmail.com   
Principal Investigator: Andrea Ensini         
Poland
Zeromski Hospital Not yet recruiting
Kraków, Poland
Contact    503 198 460    jdorttra@interia.pl   
Principal Investigator: Julian Dutka         
Hospital Miejski Zabrze Recruiting
Zabrze, Poland
Contact    +48601235093    hawranekmm@o2.pl   
Principal Investigator: Marek Hawranek         
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
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Study Chair: Beate Hansen, VP, PhD Vice President, Global Clinical Strategy

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Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT03768128     History of Changes
Other Study ID Numbers: 16-4049-12
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 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: No

Additional relevant MeSH terms:
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Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases