Knee osteoarthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years old; 2. Patients who need primary or unilateral total knee arthroplasty; 3. The subject / guardian can understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. The contraindications of TKA were as follows (1) Patients with lower limb paralysis or neuropathic joint disease (Charcot joint); (2) Patients with neuromuscular dysfunction of lower limbs (e.g. sequelae of poliomyelitis, myasthenia, etc.) may lead to postoperative knee instability, abnormal gait or difficulty in recovery; (3) Severe systemic disease (severe diabetes, serious heart disease, severe liver and kidney dysfunction, active tuberculosis infection, hemorrhagic disease); (4) Patients with active infection around knee joint or all over the body. 2. Deep venous thrombosis of the affected limb; 3. The affected limb has a history of knee joint surgery, trauma or fracture, which affects the evaluation and operation safety of the project; 4. The subjects were immunosuppressed and suffered from autoimmune diseases or immunosuppressive disorders. For example, the patient is receiving immunosuppressive therapy (high-dose cortisol, cytotoxic drugs, anti lymphocyte serum, or high-dose radiation) or has acquired immunodeficiency syndrome; 5. Pregnant or lactating women; 6. The subjects have participated in clinical studies of other drugs, biological agents or devices in the last three months; 7. Patients with known excessive drinking or drug abuse; 8. The researcher thinks that it is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correction rate of lower limb alignment after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hospital for special surgery score;knee society score;The Western Ontario and McMaster Universities Score;Brief Health Status Scale; | — |
Countries
China
Contacts
Peking Union Medical College Hospital