None listed
Conditions
Interventions
Drug : According to the randomization results, the knee assigned to the experimental group receives a subcutaneous injection of 3 vials (4,500 IU) of Tergase Inj., while the contralateral knee is assi
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult males and females aged 60 years or older and 85 years or younger. 2) Patients scheduled for bilateral total knee arthroplasty due to degenerative knee osteoarthritis with a Kellgren-Lawrence grade of III or IV confirmed by imaging within the last 4 weeks. 3) Patients experiencing knee joint pain of 5 or higher on a 10-point Visual Analogue Scale (VAS) during daily activities, such as walking on flat ground. 4) Patients with the willingness and ability to follow the physician's instructions, including joint exercises. 5) Patients classified as American Society of Anesthesiologists (ASA) Physical Status Class I or II. 6) Patients who have received a full explanation of the clinical trial and have voluntarily provided written informed consent to participate.
Exclusion criteria
Exclusion criteria: 1) Participants or their family members with ongoing or a history of autoimmune diseases. 2) Patients with secondary osteoarthritis of the knee. 3) Patients with inflammatory arthritis (such as rheumatoid arthritis, lupus arthropathy, psoriatic arthritis) or crystal-induced arthropathy. 4) Patients with a serum protein level of 5.5 g/dL or less. 5) Patients with clinical laboratory results that are contraindications for Total Knee Arthroplasty (TKA): ? WBC 12,000/µL ? CRP >10 mg/L ? Hb 1.5 ? eGFR 3× Upper Limit of Normal (ULN) ? FBS >200 mg/dL 6) Patients with a history of drug abuse or dependence. 7) Presence of local infection or sepsis in the affected lower limb, or a history of neurological abnormalities within the past 6 months. 8) History of major joint surgery within 90 days. 9) Patients who received systemic steroid treatment within 3 months prior to surgery. 10) Patients who sustained a serious injury or received an injection in the target knee that may interfere with evaluation within 3 months prior to the screening visit. 11) Patients with infections requiring hospitalization and administration of antibiotics or antimicrobics. 12) Presence of any clinically significant health abnormality that may affect the completion of the study: ? Congenital heart defects, cardiovascular or renal dysfunction, or uncontrolled diabetes. ? Lower limb neuromuscular abnormalities: Neuromuscular diseases affecting the lower limbs. ? Severe bleeding disorders: Hemorrhage or coagulation disorders. ? Severe knee instability: Instability that cannot be corrected with cruciate-retaining TKA. ? Knee deformity: Flexion contracture =30° or varus/valgus deformity =30° ? Opioid dependence: Consumption of =100 mg per week of morphine equivalent opioids for more than 3 months prior to surgery. ? Inability to assess pain: Patients unable to perform pain assessment using VAS (including cognitive or language impairment). ? Patients with venous congestion. ? Morbid obesity: Body Mass Index (BMI) >40 kg/m² 13) History of shock or hypersensitivity to Tergase inj. or its components. 14) Patients deemed unsuitable for this study by the investigator, such as those with psychiatric disorders. 15) Patients currently participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Composite Edema Index (CEI) The CEI is calculated as the average percentage change in circumference at four specific locations of the leg: calf (thickest part), suprapatellar (just above the patella), infrapatellar (just below the patella), and thigh (10 cm above the patella). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Leg Circumference Swelling Rate (%);Change in Pain Intensity measured by Visual Analogue Scale (VAS);Change in Range of Motion (ROM) of the Knee Joint;Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC);Soft Tissue and Subcutaneous Fat Thickness via Lower extremity CT;Inflammatory Biomarkers: CRP and Amyloid);Inflammatory Biomarkers: Amyloid;Incidence of Postoperative Complications;Incidence of Adverse Events (AEs);Vital Signs ;Physical Examination Findings;Clinical Laboratory Test Parameters | — |
Countries
Korea, Republic of
Contacts
Public ContactMansoo Kim
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed