Safety and Performance of the Journey™ II UNI Unicompartmental Knee System

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.

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.

• 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.
• Body Mass Index (BMI) > 40.
• Collateral ligament insufficiency.
• Active infection, treated or untreated, systemic or at the site of the planned surgery or previous intra-articular infections.
• Incomplete or deficient soft tissue surrounding the knee.
• 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.
• Diagnosis of an immunosuppressive disorder.
• Known allergy to study device or one or more of its components.
• Pregnant or planning to become pregnant during the course of the study.
• 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