Journey™ UNI Post Market Clinical Follow-Up



Status:Recruiting
Conditions:Osteoarthritis (OA), Orthopedic
Therapuetic Areas:Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:1/6/2019
Start Date:April 11, 2018
End Date:March 1, 2024
Contact:Tracey Brengola
Email:tracey.brengola@smith-nephew.com
Phone:978-749-1491

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Follow-Up of Subjects With a Journey™ UNI Unicompartmental Knee System Implant

This is a retrospective/prospective, open-label single cohort, multicenter study to collect
relevant clinical data from 147 subjects with unicompartmental degeneration of the knee in
whom the Journey UNI UKS was previously implanted.

The purpose of the current investigation is to assess the safety and effectiveness of the
JOURNEY UNI Unicompartmental Knee System (UKS) in patients with non-inflammatory degenerative
joint disease (NIDJD) of the knee who previously had the Journey UNI UKS implanted. This
clinical study will prospectively evaluate the 36 and 60-month safety and performance of the
JOURNEY UNI UKS in patients with NIDJD of the knee who required lateral or medial knee
compartment replacement.

Inclusion Criteria:

1. Between 12 and 48 months previously, subject had unicompartmental knee replacement
implanted for unicompartmental, NIDJD including OA, traumatic arthritis, avascular
necrosis, for correction of functional deformity, or to repair a fracture that was
unmanageable using other techniques.

2. Subject received a Journey UKS implant (consisting of a femoral component, tibial
baseplate, and a tibial insert).

3. Subject was considered skeletally mature at the time of surgery and was at least 18
years of age.

4. Subject is willing to have retrospective data collected and to participate in required
prospective follow-up visit(s) at the investigational site and to complete study
procedures and questionnaires.

5. Subject has consented to participate in the study by signing the Institutional Review
Board (IRB)/Ethics Committee (EC)-approved informed consent form (ICF).

Exclusion Criteria:

- Subject has Body Mass Index (BMI) > 40 within 1 month of surgery. 2. Subjects who have
received the Journey UNI UKS as part of a revision surgery.

3. Subject has a condition that may interfere with the unicompartmental knee
arthroplasty (UKA) survival or outcome (e.g. Paget's or Charcot's disease, vascular
insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal
insufficiency or neuromuscular disease).

4. Subject has a known allergy to study device or one or more of its components.

5. Subject, in the opinion of the Principal Investigator (PI), has an emotional or
neurological condition that would preempt his/her ability or willingness to
participate in the study including mental illness, mental retardation, drug or alcohol
abuse.

6. Subject is entered in another investigational drug, biologic, or device study or
has been treated with an investigational product in the past 30 days.

7. Subject is known to be at risk for loss to follow-up, or failure to return for
scheduled visits.
We found this trial at
4
sites
1550 North Northwest Highway
Park Ridge, Illinois 60068
Principal Investigator: James Bresch, MD
Phone: 847-824-3198
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Park Ridge, IL
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London, Ontario
Principal Investigator: Douglas Naudie, MD
Phone: 519-685-8500
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London,
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Nashville, Tennessee 37209
Principal Investigator: Stuart Smith, MD
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Nashville, TN
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3655 Crossings Drive
Prescott, Arizona 86305
Principal Investigator: Bertrand Kaper, MD
Phone: 480-305-0034
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Prescott, AZ
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