Knee osteoarthritis
Conditions
Interventions
Control group:Oral placebo
Experimental group:Oral serrapeptase enteric-coated tablets
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: Aged between 18 and 80 years at the time of enrollment. 2. Surgical Procedure: Scheduled to undergo primary unilateral total knee arthroplasty (TKA). 3. Physical Status: Classified as American Society of Anesthesiologists (ASA) Physical Status I, II, or III. 4. Informed Consent: Willing and able to provide written informed consent prior to participation in the study.
Exclusion criteria
Exclusion criteria: 1. Elevated preoperative inflammatory markers (C-reactive protein >10 mg/L or interleukin-6 >15 pg/mL); 2. Preoperative hemoglobin 1.5 times the upper limit of normal); 3. Severe knee deformity, stiffness, or ankylosis; 4. Hepatic or renal dysfunction (ALT or AST >2 times the upper limit of normal; serum creatinine >2 times the upper limit of normal) or history of kidney stones; 5. Known hypersensitivity to any medications required during the study; 6. History of skeletal radiotherapy, bone metastases, or malignant bone tumors; 7. Patients with metabolic bone diseases other than osteoporosis or with a prior history of hypercalcemia; 8. Esophageal motility disorders or severe esophagitis, including gastritis or peptic ulcers; 9. Patients receiving high-dose corticosteroid therapy; 10. Patients deemed unsuitable for inclusion by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lower limb swelling;Joint pain at rest and during movement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Opioid consumption;Functional recovery;Coagulation function;Inflammatory markers;Bleeding events;Postoperative satisfaction; | — |
Countries
China
Contacts
Public ContactZongke Zhou
West China School of Medicine and West China Hospital, Sichuan University
Outcome results
None listed