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

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

— JII-Uni  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03768128
• Other study ID #: 16-4049-12
• Status: Active, not recruiting
• Start date: August 10, 2018
• Est. completion date: June 30, 2025

Study information

• Verified date: December 2023
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 154
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Journey™ II UNI Unicompartmental Knee System
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.

Locations

Country	Name	City	State
Italy	Poliambulanza Institute Hospital Foundation	Brescia
Italy	Istituto Clinico Villa Aprica	Como
Poland	Zeromski Hospital	Kraków
Poland	Hospital Miejski Zabrze	Zabrze
United States	Rush University Medical Center	Chicago	Illinois
United States	OrthoIllinois, LTD	Rockford	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

United States,  Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival 5 years postoperatively		5 years
Secondary	Device-related adverse events	All AEs will be collected and reported	5 year
Secondary	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