Osteoarthritis of the knee
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients requiring primary unilateral TKA due to severe osteoarthritis of the knee; 2. Aged 18 to 80 years; 3. The American Society of Anesthesiologists (American Society of Anesthesiologists, ASA) classification (anesthesia risk assessment) is I~III level.
Exclusion criteria
Exclusion criteria: 1.Patients with heart, lung and other important organ failure; 2.Abnormal liver and renal function (ALT, AST, > 1.5 times normal, blood BUN >-8.3 mmol /L, blood Scr >115 umol/L); 3.Diabetic patients with poor control of blood glucose levels and identified by the investigator as at risk of infection; 4.Combined with consciousness disorder or mental illness; 5.Have a history of open knee surgery; 6.Neuromuscular dysfunction affecting lower limb function; 7.Patients with severe coagulation dysfunction; 8.Combined with severe internal and surgical diseases or weak constitution, unable to tolerate surgery; 9.Severe unstable and ligament-preserved TKA cannot be cured; 10.There are active infection foci (systemic or local infection lesions) in the body; 11.Serious osteoporosis, metabolic bone disease, radioactive bone disease and tumor around the knee joint; 12.Family planning, lactating and pregnant women throughout the clinical study period; 13.Participated in other clinical trials within 3 months; 14.The investigator considers it inappropriate to participate in the clinical trial for other reasons; 15.Knee flexion deformity >= 30 degree or varus deformity >= 30 degree; 16.People who are allergic to the drugs used in this study; 17.Addicts to opiates; 18.People with speech disorders and an inability to complete Visual analogue scale (VAS).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dosage of morphine hydrochloride injection for postoperative salvage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative VAS pain score;Knee HSS score;Range of knee motion;Daily walking distance;Postoperative inflammatory markers (CRP, IL-6);LOS (length of stay);Incidence of complications; | — |
Countries
China
Contacts
West China Hospital, Sichuan University