Clinical trial NCT03768128: Safety and Performance of the Journey™ II UNI Unicompartmental Knee System
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-inflammatory Degenerative Joint Disease (NIDJD) of the Knee
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-07
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Implant survival 5 years postoperatively
timeFrame: 5 years
Secondary outcomes:
measure: Device-related adverse events
timeFrame: 5 year
measure: Radiographic assessments
timeFrame: 5 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Rockford
country: United States
facility: OrthoIllinois, LTD
state: Illinois
city: Brescia
country: Italy
facility: Poliambulanza Institute Hospital Foundation
city: Como
country: Italy
facility: Istituto Clinico Villa Aprica
city: Kraków
country: Poland
facility: Zeromski Hospital
city: Zabrze
country: Poland
facility: Hospital Miejski Zabrze
Study officials:
References: