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

NCT03768128 | Completed

• 1 other identifier: 16-4049-12
• Study Type: observational
• Target: 154
• Locations: 3 countries
• Sites: 6

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 medial knee compartment replacement. Clinical, radiographic, health economic and safety outcomes will be evaluated.

Conditions

Non-inflammatory Degenerative Joint Disease (NIDJD) of the Knee

Outcome Measures

Primary Outcomes (1)

• Implant survival 5 years postoperatively

  5 years

Secondary Outcomes (2)

• Device-related adverse events

  5 year

• Radiographic assessments

  5 year

Interventions

Journey™ II UNI Unicompartmental Knee System DEVICE

Journey™ II UNI UKS is a CE Marked medical device. The device has been designed to treat both medial and lateral unicompartmental disease. It is a comprehensive system designed to allow surgeons to perform UKA. It is comprised of the following anatomic components: Oxidized zirconium femoral components Titanium tibial components with a grit-blasted surface Polyethylene tibial insert components The device is asymmetric and is available in oxidized zirconium to reduce wear and increase implant longevity.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (6)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

OrthoIllinois, LTD

Rockford, Illinois, 61114, United States

Location

Poliambulanza Institute Hospital Foundation

Brescia, 25124, Italy

Location

Istituto Clinico Villa Aprica

Como, 22100, Italy

Location

Zeromski Hospital

Krakow, 31-913, Poland

Location

Hospital Miejski Zabrze

Zabrze, 41-803, Poland

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: December 7, 2018
• Study Start: August 10, 2018
• Primary Completion: May 19, 2025
• Study Completion: May 19, 2025
• Last Updated: February 27, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); PL (2); US (2)