JOURNEY™ II CR Total Knee System

Running, not enrolling

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT02440672

Run by

Smith & Nephew, Inc.

People needed

170

Starts

2015-09-01

Expected to finish

2028-06-01

Last updated by the study team

2026-06-12

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects MUST meet ALL of the following criteria for inclusion in the study:
• Has signed the IRB/EC approved ICF specific to this study prior to study participation
• Is a male or female ≥ 22 and ≤ 75 years of age presenting with degenerative joint disease (DJD) of the knee
• 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
• Is able to read and understand the approved Informed Consent Form and Patient Reported Outcome (PRO) assessments (written and oral)
• Is in general good health (as determined by the Investigator) based on screening assessments and medical history
• Is independent, ambulatory, and can comply with all post-operative evaluations
• plans to be available through ten (10) years post-operative follow-up

You may not qualify if…

• 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

Where it is running

• Orthopedic Institute of the West — Phoenix, Arizona, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Anne Arundel Health System Research Institute, Inc — Annapolis, Maryland, United States
• Center for Hip and Knee Replacement at Columbia University Medical Center — New York, New York, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• The Lindner Research Center, Musculo-Skeletal Division - The Christ Hospital Health Network — Cincinnati, Ohio, United States
• Hospital Parc Taulí Servei de Cirurgia Ortopèdica I Traumatologia — Barcelona, Spain
• Royal National Orthopaedic Hospital NHS Trust — Stanmore, United Kingdom
• Barts Health NHS Trust — Whitechapel, United Kingdom

Full record on ClinicalTrials.gov

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