Knee osteoarthritis
Conditions
Interventions
None listed
Sponsors
International University of Health and Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age between 20 years and 75 years Patient belongs to Japanese ethnic group Willing and able to comply with the study Protocol Informed Consent Document (ICD) signed by patient Osteoarthritis in one or more compartments of the knee Non-surgical treatment options have failed to provide relief for symptoms Preoperative radiographic evidence of joint degeneration that cannot be treated in non-operative fashion Knee distal femoral varus deformity between 5 and 30 degrees or distal femur in 5-7 degrees of valgus (normal knee anatomy) Independent of study participation, patient is a candidate for commercially available Journey II BCS Total Knee System in accordance with approved indication
Exclusion criteria
Exclusion criteria: Patients who have an existing medical condition that would, in the opinion of the Investigator, compromise their participation and follow-up in the study No previous or active infection in the affected joint or systemic infection Chronic long acting narcotic pain medication Inflammatory polyarthritis Women who are pregnant Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation, in the opinion of the investigator Participation in a clinical trial of another Investigational Drug or device within the past 30 days Active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated. Patients with carcinoma in situ of the uterine cervix treated definitely more than 1 year prior to enrollment may enter the study Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint A member of a protected population (e.g., prisoner, mentally incompetent); History of partial or total knee arthroplasty for the ipsilateral knee. History of partial or total hip arthroplasty
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| KOOS-ADL | — |
Countries
Japan
Contacts
Public ContactTakashi Yanagawa
Smith & Nephew Orthopaedics KK Clinical Operations, Research & Engineering
Outcome results
None listed