Non-inflammatory Degenerative Joint Disease (NIDJD) of the KneeJII-UniNCT03768128
Safety and Performance of the Journey™ II UNI Unicompartmental Knee System
An observational study of Non-inflammatory Degenerative Joint Disease (NIDJD) of the Knee, run by Smith & Nephew, Inc. at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-inflammatory Degenerative Joint Disease (NIDJD) of the Knee
- What is being tested?
- Journey™ II UNI Unicompartmental Knee System
- Type of treatment
- Medical device
- How many people
- 154 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 10 Aug 2018to 19 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States2 sites
Rush University Medical Center
Chicago, Illinois, 60612
OrthoIllinois, LTD
Rockford, Illinois, 61114
Italy2 sites
Poliambulanza Institute Hospital Foundation
Brescia, 25124
Istituto Clinico Villa Aprica
Como, 22100
Poland2 sites
Zeromski Hospital
Krakow, 31-913
Hospital Miejski Zabrze
Zabrze, 41-803
About this study
Official title: 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.
Read the 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.
- Being tested
- Journey™ II UNI Unicompartmental Knee System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Journey™ II UNI Unicompartmental Knee SystemDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival 5 years postoperatively
Measured: 5 years
Secondary outcomes (2)
Device-related adverse events
All AEs will be collected and reported
Measured: 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
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start10 Aug 2018
- Primary completion19 May 2025
- Study completion19 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-inflammatory Degenerative Joint Disease (NIDJD) of the KneeStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768128
- Sponsor's protocol ID
- 16-4049-12
- Acronym
- JII-Uni
- Status last verified
- Sep 2024
- First submitted
- 27 Nov 2018
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Post-Market Clinical Follow-up Study to Evaluate the Safety and Performance of the Journey™ II UNI Unicompartmental Knee System
- ClinicalTrials.gov ID
- NCT03768128
- Acronym / sponsor ID
- JII-Uni / 16-4049-12
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Subjects must meet all of the following criteria for inclusion in the study.
Key exclusion criteria (14 listed)
- Subjects meeting any of the following criteria must be excluded from participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Journey™ II UNI Unicompartmental Knee SystemJourney™ 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. | Device | – |
Primary outcome
Implant survival 5 years postoperatively
Time frame: 5 years
2 secondary outcomes
Device-related adverse events
Time frame: 5 year
Radiographic assessments
Time frame: 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-inflammatory Degenerative Joint Disease (NIDJD) of the Knee, run by Smith & Nephew, Inc. at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Italy, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival 5 years postoperatively (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.