Knee osteoarthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with 21 years old <= actual age < 75 years old; 2. Patients who are able to perform surgery and follow-up with good compliance; 3. Patients who need unilateral knee replacement; 4. Subjects with good functional ligaments; 5. The subjects who voluntarily participate in the test and are willing to sign the informed consent in writing.
Exclusion criteria
Exclusion criteria: 1. Subjects whose major joints (hip and knee joints) of the same side of the lower limb have been replaced; 2. Subjects who have participated in clinical research of other investigational drugs or devices in the past 3 months; 3. Patients with fixed flexion contracture or varus greater than 15 degrees; 4. Patients with ankylosis of hip or ankle; 5. Patients who are known or suspected to be allergic to polyethylene, titanium, cobalt, chromium or ferrous materials; 6. Patients with immunosuppressive state, autoimmune disease or immunosuppressive disorder; 7. Subjects who are unable to support and / or fix the prosthesis due to diseases (such as tumor, severe osteoporosis, or metabolic osteopathy, etc.); 8. Subjects who could not understand the requirements of participating in the study or could not complete the follow-up plan of the study; 9. Other researchers think it is not suitable for this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of adverse events;Deviation Angle of limb alignment;the Western Ontario and McMaster Universities Osteoarthritis Index;Knee Society Score; | — |
Countries
China
Contacts
the First Affiliated Hospital of PLA Army Medical University