Active, not recruitingNo phase
JOURNEY™ II CR Total Knee System
Key facts
- Who runs it
- Smith & Nephew, Inc.
- Where
- Annapolis, Chicago, Cincinnati, New York, Phoenix, and Winston-Salem, United StatesSee the 6 sitesAlso in 2 other countries, 3 sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 170 people enrolled
- Started
- Sept 2015
- Expected to end
- Jun 2028
- Type of study
- Observational
- Treatments tested
- JOURNEY™ II CR Total Knee System (J II CR TKS)
- Record updated
- 12 June 2026
Who can take part
- Age
- 22 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:
Where in United States
Also in 2 other countries, 3 sites
- Anne Arundel Health System Research Institute, Inc.Annapolis, United StatesNo longer taking part
- Rush University Medical CenterChicago, United StatesNo longer taking part
- The Lindner Research Center, Musculo-Skeletal Division - The Christ Hospital Health NetworkCincinnati, United StatesNo longer taking part
- Center for Hip and Knee Replacement at Columbia University Medical CenterNew York, United StatesNo longer taking part
- Orthopedic Institute of the WestPhoenix, United StatesNo longer taking part
- Wake Forest UniversityWinston-Salem, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- Device:JOURNEY™ II CR Total Knee System (J II CR TKS)
Subjects having TKA with JOURNEY™ II CR Total Knee System
Treatment: JOURNEY™ II CR Total Knee System (J II CR TKS)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Prospective, Non-randomized, Single Cohort, Multicenter Study to Evaluate the Clinical Outcomes of Total Knee Arthroplasty (TKA) Using the JOURNEY™ II CR Total Knee System
- Record updated
- 12 June 2026