JOURNEY™ II CR Total Knee System (J II CR TKS): TKA with Journey II CR Total Knee System
Study summary
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.
Eligibility
Sex
ALL
Min age
22 Years
Max age
75 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Equivalence in 1 year post-operative mean Range of Motion (ROM) in subjects receiving the J II CR TKS as compared to the literature reference mean ROM — 1 year post-op analysis
Non-inferiority of the survival rate of the J II CR TKS with the reference survival rate of a literature reference at 5 and 10-years post-operatively — Up to 10 year post-operative analysis
Trial sites (9)
Facility
City
Region
Status
Orthopedic Institute of the West
Phoenix
Arizona
Rush University Medical Center
Chicago
Illinois
Anne Arundel Health System Research Institute, Inc
Annapolis
Maryland
Center for Hip and Knee Replacement at Columbia University Medical Center
New York
New York
Wake Forest University
Winston-Salem
North Carolina
The Lindner Research Center, Musculo-Skeletal Division - The Christ Hospital Health Network
Cincinnati
Ohio
Hospital Parc Taulí Servei de Cirurgia Ortopèdica I Traumatologia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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