Status:
COMPLETED
Safety and Performance of the Journey™ II UNI Unicompartmental Knee System
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Non-inflammatory Degenerative Joint Disease (NIDJD) of the Knee
Eligibility:
All Genders
18+ years
Brief Summary
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 m...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 10 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 19 2025
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT03768128
Start Date
August 10 2018
End Date
May 19 2025
Last Update
July 28 2025
Active Locations (6)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612
2
OrthoIllinois, LTD
Rockford, Illinois, United States, 61114
3
Poliambulanza Institute Hospital Foundation
Brescia, Italy, 25124
4
Istituto Clinico Villa Aprica
Como, Italy, 22100