Knee osteoarthritis
Conditions
Interventions
None listed
Sponsors
Stryker Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients are candidate for primary TKA. 2) Patients have diagnosis of OA. 3) Patients are age 20 or over. 4) Patient, who can walk independently without assistance person. 5) Patients, who agree on an IRB-approved, study specific Informed Patient Consent Form 6) Patients are willing and able to comply with postoperative scheduled evaluations
Exclusion criteria
Exclusion criteria: 1) Patients have bacterial infectious disease or have risk highly of bacterial infection. 2) Patients requiring revision surgery. 3) Patients, who are severe Baker's leg (FTA < 165 degree). 4) Patients had bone osteotomy to tibia. 5) Patients, who are morbidly obese, defined as having a Body Mass Index (BMI) > 40. 6) Patients who is pregnant female or maybe so. 7) Patients who have a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device. 8) Patients with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy). 9) Patients who are immunologically suppressed or receiving chronic steroids. 10) Patients who are judged ineligible with reasonable reason by primary doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic evaluation. Functional Score. Patients satisfaction. | — |
Countries
Japan
Contacts
Public ContactSatoru Motohashi
Stryker Japan K.K. Clinical Affairs
Outcome results
None listed