Severe knee pain and disability
Conditions
Interventions
None listed
Sponsors
Zimmer K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients which are indicated for total knee replacement surgery suffering from severe knee pain and disability due to degenerative joint disease including the following: osteoarthritis (OA), primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle or pseudo gout, posttraumatic arthritis and varus, valgus, or flexion deformities. -Patient is in stable health and able to undergo surgery and participate in a follow-up program based upon physical examination and medical history. -Patient is willing and able to cooperate in follow-up program. -Patient or patient's legal representative has signed a Patient Informed Consent Form.
Exclusion criteria
Exclusion criteria: -Patient is skeletally immature. -Patient known to be pregnant. -Varus/valgus deformity with mechanical axis >20 degrees. -Fixed flexion deformity >15 degrees. -Patients with grossly insufficient femoral or tibial bone stock, e.g., due to osteoporosis, metabolic bone disease, congenital anomaly, or previous surgery to the index joint that could affect outcome. -Patients with previously failed knee endoprosthesis of any kind. -Patients with a previous history of infection in the affected joint. -Patient is unwilling or unable to cooperate in a follow-up program.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical outcomes evaluated by the Knee Society assessment scoring system | — |
Secondary
| Measure | Time frame |
|---|---|
| -The functional outcome evaluated by the Knee Society functional scoring system -Radiographic outcome evaluated by anterial -posterial and medial-lateral radiographs -Patient's general health status assessment using the Euro-Qol-5D scoring system (EQ-5D) -The survivorship meaning that the prosthesis has not been explanted, nor is a revision planned or pending | — |
Countries
Japan,Europe
Contacts
Public ContactAkira Kashima
Zimmer K.K. Clinical Affairs
Outcome results
None listed