The subject components are indicated for total knee arthroplasty performed for rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, failed osteotomies, or failed unicompartmental replacement.
Conditions
Interventions
None listed
Sponsors
Smith & Nephew KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. require TKA due to rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis, failed osteotomies, or failed unicompartmental replacement 2. have all cruciate and collateral ligaments intact in the index joint 3. be an adult patient that in the judgement of the Investigator is skeletally mature 4. be willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires 5. consent to participate in the study by signing the IRB/EC approved informed consent form 6. be patient with the JURNEY II XR Knee system as determined by the principal investigator, independent of this study, to be the best treatment for the patient, independent of this study
Exclusion criteria
Exclusion criteria: 1. have any of the following conditions in the index joint: a. Intra-articular corticosteroid therapy (or any other intra-articular therapy) in the study knee within 3 months of study enrollment b. Significant varus or valgus deformities (>15 angle) c. Incomplete or insufficient tissue surrounding the knee d. Collateral ligament insufficiency e. Inadequate bone stock to support the device (e.g., severe osteopenia/osteoporosis) or will require use of femoral and tibial stems f. History of prior TKA 2. have any of the following conditions in the contralateral joint: a. a previous TKA as a revision for a failed total or unicondylar knee arthroplasty b. a primary TKA or unicondylar knee arthroplasty that is not fully healed and well-functioning as determined by the Investigator 3. have any of the following conditions of the hip: a. a previous contralateral or ipsilateral revision hip arthroplasty b. ipsilateral hip arthritis resulting in flexion contracture c. previously received an ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty that is not fully healed and well-functioning as determined by the Investigator 4. have a diagnosis of an immunosuppressive disorder 5. have an active infection, treated or untreated, systemic or at the site of the planned surgery 6. have conditions that may interfere with the TKA survival or outcome, including but not limited to: Paget's disease, Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease 7. have a BMI > 40 8. be facing current or impending incarceration 9. have a known allergy to study device or one or more of its components 10. have, in the opinion of the Investigator, an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to demonstrate the safety and performance of the JOURNEY II XR by evaluating implant survival rates. | — |
Secondary
| Measure | Time frame |
|---|---|
| The EuroQol Five Dimensions Questionnaire (EQ-5D-5L) The Forgotten Joint Score-Knee (FJS-12) The Knee injury and Osteoarthritis Outcome Scores (KOOS) Radiographic outcomes Range of Motion (RoM) Adverse Events (AEs) | — |
Countries
Japan
Contacts
Public ContactWataru Taguchi
Smith & Nephew KK Clinical Study Management, Clinical Affairs, Japan
Outcome results
None listed