Osteoarthritis
Conditions
Interventions
Experimental Group:LKR202 injection for intra-articular administration.
Control group:Placebo intra-articular injection
Sponsors
Shanghai First People's Hospital
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: (1) Age between 35 and 75 years old (inclusive), no gender restriction; (2) Diagnosed with unilateral or bilateral knee osteoarthritis according to the "Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis" (2024 edition); (3) The WOMAC pain VAS score during level walking (A1) of the study knee joint is > 30mm and <= 80mm, and the WOMAC pain VAS score during level walking (A1) of the contralateral knee joint is <= 30mm; (4) Standing X-ray examination within 3 months before screening or at the time of screening shows Kellgren-Lawrence grade I-III, and the grade of the contralateral knee joint does not exceed that of the study knee joint; (5) 18 kg/m2 <= BMI <= 30 kg/m2; (6) Willing to participate in the clinical trial, understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: History of local/systemic treatment: (1) Patients with the following previous treatments or plans to have the following treatments during the study: 1) Use of any analgesic medication (including Chinese medicine) or therapy (physical therapy, acupuncture, massage) for osteoarthritis within 1 week before enrollment or within 5 drug half-lives, whichever was longer; 2) Systemic use of glucocorticoids within 3 months before enrollment; 3) Intra-articular injection of glucocorticoids and platelet-rich plasma within 6 months before enrollment; 4) injected with viscoelastic supplements in either knee within 6 months before enrollment; 5) have undergone any major surgery, arthroplasty, or arthroscopy in the study knee or other lower extremity joint within 6 months before enrollment or are planning to undergo lower extremity surgery during the study period; 6) received stem cell therapy within 12 months before enrollment; Comorbidities/medical history: (2) Patients with active knee joint infection or skin ulceration, infection or other medical conditions affecting the injection; (3) Inability to walk (except those who used a walking aid >=12 weeks before screening and used the aid in the same manner during the trial); (4) Combined hip, knee and ankle osteoarthritis or obvious loss of joint space of patellofemoral joint; (5) Secondary osteoarthritis with clear etiology, such as infectious knee osteoarthritis, traumatic knee osteoarthritis caused by intra-articular fracture, rheumatoid knee osteoarthritis, gougy knee osteoarthritis, etc. (6) Knee joint injury caused by other reasons, or inflammatory pain diseases involving the knee joint or diseases affecting the knee joint (including but not limited to: hemorrhagic arthritis, femoral head epiphyseolysis, bone tuberculosis, bone tumors, hemorrhagic pigmented villonodular synovitis, metabolic bone disease, psoriatic arthritis, symptomatic cartilage calcification); (7) Other lower extremity diseases that may interfere with the efficacy evaluation of knee joint, such as gout, fibromyalgia, significant valgus/varus deformity of knee joint, ligament relaxation, peripheral vascular disease of leg such as lower extremity varicose veins, etc. (8) Meniscus injury or loose body requiring surgery during the study period; (9) Patients with blood system diseases or abnormal coagulation function that cannot be corrected; (10) Patients who were taking antiplatelet aggregation or anticoagulant drugs and could not stop taking them; (11) Patients with severe diseases of important organs (cardiovascular system, lung, liver, kidney and nervous system) or autoimmune diseases; (12) Laboratory tests: ALT > 2×ULN or AST > 2×ULN, Ccr 2×ULN; (13) Having a clear history of mental disorders, or having a history of psychotropic drug abuse or drug use; History of allergies: (14) Allergic or intolerant to acetaminophen or tramadol; (15) History of allergy to sodium hyaluronate or other materials involved in this trial; Others: (16) Pregnant, lactating, or planning to become pregnant during the study period; (17) Those who had participated in any other clinical trial within 3 months before signing the informed consent; (18) Other investigators judged that they were not suitable to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence, severity, and relationship to the investigational drug of adverse events/serious adverse events.;Changes in vital signs, physical examination findings, laboratory test results, and electrocardiogram before and after drug administration.; | — |
Countries
China
Contacts
Public ContactQiugen Wang, Xueying Ding
Shanghai First People's Hospital
Outcome results
None listed