Partial knee implant study shows promising 5-Year results
NCT ID NCT03768128
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at the safety and performance of the Journey II UNI partial knee replacement in 154 people with knee arthritis. The main goal was to see how many implants were still working well 5 years after surgery. Researchers also tracked any side effects and checked X-rays to see how the implant and bone were doing over time.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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154 people
The number who actually took part.
- Started
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Aug 2018
- Finished
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May 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital Miejski Zabrze
Zabrze, 41-803, Poland
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Istituto Clinico Villa Aprica
Como, 22100, Italy
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OrthoIllinois, LTD
Rockford, Illinois, 61114, United States
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Poliambulanza Institute Hospital Foundation
Brescia, 25124, Italy
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Rush University Medical Center
Chicago, Illinois, 60612, United States
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Zeromski Hospital
Krakow, 31-913, Poland