JOURNEY™ II CR Total Knee System

Smith & Nephew

Status: Active, not recruiting

Conditions: Osteoarthritis, Knee

Treatments: Device: JOURNEY™ II CR Total Knee System (J II CR TKS)

Study type: Observational

Funder types: Industry

Identifiers

NCT02440672

13-4049-06

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement.

Full description

This is a prospective, non-randomized, single cohort, multicenter study to evaluate the clinical outcomes of TKA using the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement. One hundred and seventy (170) subjects will be enrolled at up to 18 clinical sites globally. Follow-up clinical assessments will be performed at 3 months, 1 year, 2 years, 5 years, and 10 years post-operatively.

Enrollment: 170 patients

Sex: All

Ages: 22 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Subjects MUST meet ALL of the following criteria for inclusion in the study:

1. Has signed the IRB/EC approved ICF specific to this study prior to study participation

2. Is a male or female ≥ 22 and ≤ 75 years of age presenting with degenerative joint disease (DJD) of the knee

3. Is a candidate for primary total knee arthroplasty with the JOURNEY™ II CR Total Knee System due to DJD, defined by one of the following:

   • Post-traumatic arthritis
   • Osteoarthritis
   • Degenerative arthritis

4. Is able to read and understand the approved Informed Consent Form and Patient Reported Outcome (PRO) assessments (written and oral)

5. Is in general good health (as determined by the Investigator) based on screening assessments and medical history

6. Is independent, ambulatory, and can comply with all post-operative evaluations

7. plans to be available through ten (10) years post-operative follow-up

Exclusion criteria

1. Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:

• Any of the following conditions in the index joint:

  • does not require patella resurfacing
  • has received a TKA or unicondylar arthroplasty
  • has inadequate bone stock to support the device (e.g. severe osteopenia/osteoporosis)

• Any of the following conditions in the contralateral joint:

  • has enrolled in the study for the contralateral knee
  • has received TKA as a revision for a failed total or unicondylar knee arthroplasty
  • has received a primary TKA or unicondylar knee arthroplasty that is not fully healed and well-functioning, as determined by Investigator
  • Any of the following conditions of the hip:
  • received contralateral or ipsilateral revision hip arthroplasty
  • has ipsilateral hip arthritis resulting in flexion contracture
  • has received a ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty, that is not fully healed and well-functioning, as determined by Investigator
  • Has diagnosis of an immunosuppressive disorder
  • Has presence of malignant tumor, metastatic, or neoplastic disease
  • Has family history of severe osteoporosis/osteopenia
  • Has a known allergy to study device or one or more of its components
  • Has conditions that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
  • Is receiving medication for the diagnosis of fibromyalgia
  • has a lower extremity condition causing abnormal or restricted ambulation (e.g. ankle fusion, ankle arthroplasty, previous hip fracture)
  • Is pregnant or plans to become pregnant during the study
  • Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study and complete PROs, as determined by Investigator
  • Has a BMI > 40
  • Is currently enrolled in or has participated in another investigational drug, biologic, or device study within 3 months of enrollment
  • Is currently involved in personal injury litigation or a worker's compensation claim
  • Is facing current or impending incarceration
  • Is known to be at risk for lost to follow-up, or failure to return for scheduled visits

Trial design

170 participants in 1 patient group

Device:JOURNEY™ II CR Total Knee System (J II CR TKS)

Description:

Subjects having TKA with JOURNEY™ II CR Total Knee System

Treatment:

Device: JOURNEY™ II CR Total Knee System (J II CR TKS)