Safety and Performance of the Journey™ II UNI Unicompartmental Knee System (JII-Uni)

A Prospective, Multicenter Post-Market Clinical Follow-up Study to Evaluate the Safety and Performance of the Journey™ II UNI Unicompartmental Knee System

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.

Study Overview

• Status: Completed
• Conditions: Non-inflammatory Degenerative Joint Disease (NIDJD) of the Knee
• Intervention / Treatment: Device: Journey™ II UNI Unicompartmental Knee System

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 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.

• Study Type: Observational
• Enrollment (Actual): 154

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy, 25124
    • Poliambulanza Institute Hospital Foundation
  • Como, Italy, 22100
    • Istituto Clinico Villa Aprica
• Poland
  • Krakow, Poland, 31-913
    • Zeromski hospital
  • Zabrze, Poland, 41-803
    • Hospital Miejski Zabrze
• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Rockford, Illinois, United States, 61114
      • OrthoIllinois, LTD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Implant survival 5 years postoperatively	5 years

Secondary Outcome Measures

Outcome Measure	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	5 year

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2018
• Primary Completion (Actual): May 19, 2025
• Study Completion (Actual): May 19, 2025

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Joint Diseases; Osteoarthritis
• Other Study ID Numbers: 16-4049-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No