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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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Journey™ II UNI Unicompartmental Knee System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant survival 5 years postoperatively | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Device-related adverse events | All AEs will be collected and reported | 5 year |
| Radiographic assessments | 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 |
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Inclusion Criteria:
Subjects must meet all of the following criteria for inclusion in the study.
Unicompartmental, NIDJD, including OA, traumatic arthritis, or avascular necrosis.
Eighteen (18) years of age or older at the time of surgery.
Skeletally mature in the judgement of the PI.
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.
Willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires.
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.
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States | ||
| OrthoIllinois, LTD |
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| 5 year |
| Rockford |
| Illinois |
| 61114 |
| United States |
| Poliambulanza Institute Hospital Foundation | Brescia | 25124 | Italy |
| Istituto Clinico Villa Aprica | Como | 22100 | Italy |
| Zeromski Hospital | Krakow | 31-913 | Poland |
| Hospital Miejski Zabrze | Zabrze | 41-803 | Poland |