Osteoarthritis of the knee
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients who need to undergo the initial unilateral total knee arthroplasty due to severe osteoarthritis of the knee joint; (2) Age ranging from 18 to 80 years old; (3) The preoperative classification (anesthesia risk assessment) of the American Society of Anesthesiologists (ASA) was grade I to III.
Exclusion criteria
Exclusion criteria: (1) Patients with failure of vital organs such as the heart and lungs; (2) Abnormal liver and kidney functions (ALT, AST> 1.5 times the normal value, blood BUN>-8.3 mmoll, blood Scr>115 umol/L); (3) Diabetic patients with poorly controlled blood sugar levels, who are judged by researchers to be at risk of infection; (4) Combined with consciousness disorders or mental illnesses; (5) Have a history of open knee surgery; (6) There is neuromuscular dysfunction affecting the function of the lower extremities; (7) Patients with severe coagulation dysfunction; (8) Combined with severe internal or surgical diseases or weak constitution, unable to tolerate surgery; (9) Severely unstable and incurable with ligament-preserving TKA; (10) There are active infection foci in the body (with infection lesions throughout the body or locally); (11) There is severe osteoporosis, metabolic bone disease, radiation bone disease or tumor around the knee joint; (12) Women in family planning, lactation and pregnancy throughout the entire clinical research period; (13) Those who have participated in other clinical trials within the past three months; (14) Those who the researcher deems unsuitable to participate in this clinical trial for other reasons; (15) Knee flexion deformity >= 30° or varus and valgus deformity >= 30°; (16) Those who are allergic to the drugs used in this study; (17) Opioid addicts; (18) Those with language disorders and unable to complete the Visual analogue scale (VAS) for pain.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dosage of morphine hydrochloride injection for postoperative rescue;Postoperative VAS pain score; | — |
Secondary
| Measure | Time frame |
|---|---|
| The dosage of opioids during the surgery;The dosage of anesthetic inhaled during the operation;Incidence of intraoperative hypertension;Postoperative serum cortisol and ACTH levels;Postoperative knee joint range of motion;Postoperative walking ability test;Postoperative duration of hospital stay;Incidence of postoperative complications; | — |
Countries
China
Contacts
West China Hospital, Sichuan University