Knee Osteoarthritis
Conditions
Interventions
None listed
Sponsors
Stryker Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.The subject requires a primary total knee replacement. 2.The subject is diagnosed as knee osteoarthritis. 3.The subject is over 20 year of age. 4.The subject can walk independently without caregiver. (Including the subject with a cane.) 5.The subject has signed the IRB approved, study specific informed consent form. 6.The subject is willing to participate continuously in the study.
Exclusion criteria
Exclusion criteria: 1.The subject who has an infection or is at high risk of having it. 2.The subject is revision case. 3.The subject who has had tibia osteotomy. 4.The subject who is morbidly obese. (BMI is 40 or more.) 5.The subject who is pregnant or potential pregnancy. 6.The subject has a neuromuscular or neurosensory deficiency that would limit the ability to assess. 7.The subject has a systemic disease that would limit the ability to assess. 8.The subject who has taken immunosuppressive agent or steroids consecutively that would limit the ability to assess. 9.The subject who is an inappropriate for participating in the study in the judgement of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implant rotational alignment by CT image | — |
Secondary
| Measure | Time frame |
|---|---|
| Post-operative outcome (X-ray evaluation, JOA score, Knee Society Score (2011), and EQ-5D) | — |
Countries
Japan
Contacts
Public ContactSatoru Motohashi
Stryker Japan K.K. Clinical Affairs
Outcome results
None listed