Safety and Performance of the Journeyâ„¢ II UNI Unicompartmental Knee System (NCT03768128) | Clinical Trial Compass
CompletedNot Applicable
Safety and Performance of the Journeyâ„¢ II UNI Unicompartmental Knee System
United States, Italy, Poland154 participantsStarted 2018-08-10
Plain-language summary
This clinical study will evaluate the early to midterm safety and performance of the JOURNEYâ„¢ 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✕. Correction of functional deformity.
✕. Revision procedures where other treatments or devices have failed.
✕. Treatment of fractures that are unmanageable using other techniques.
✕. 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.