Knee osteoarthritis
Conditions
Interventions
Treatment group:Intraarticular injection of cross-linked chitosan gel
Control Group:Intraarticular injection of chitosan gel
Sponsors
The Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age between 35-75 years old (including threshold), gender not limited; (2) Diagnosed as unilateral or bilateral knee osteoarthritis according to the Chinese "Guidelines for Diagnosis and Treatment of Osteoarthritis" (2018 edition); (3) Failure to respond adequately to conservative non pharmacological treatments and/or simple analgesics (such as acetaminophen); (4) The baseline study showed that the average VAS score for knee joint WOMAC pain was = 40mm and = 80mm, and the average VAS score for contralateral knee joint WOMAC pain was = 30mm; (5) Within the first 3 months of screening or during screening, standing X-ray examination showed Kellgren Lawrence grades I-III, with the contralateral knee joint grading not exceeding the study knee joint; (6)18 kg/m2 = BMI = 30 kg/m2; (7) Voluntarily participate in clinical trials, understand and sign informed consent forms.
Exclusion criteria
Exclusion criteria: Exclusion criteria: Local/systemic treatment history: (1) There are individuals who have received or plan to receive the following treatments during the study period: Have used any medication (including traditional Chinese medicine) or therapy for treating osteoarthritis within the previous week of randomization; Systematic use of glucocorticoids within the first 3 months of randomization; Within the first 6 months of randomization, the knee joint cavity was injected with glucocorticoids; Random injection of viscoelastic supplements into any knee joint within the first 6 months; Within the first 6 months of randomization, the knee or other lower limb joints have undergone any major surgery, arthroplasty, or arthroscopy, or are planned to undergo lower limb surgery during the study period; Previously received treatment with stem cells or platelet rich plasma; Combined diseases/medical history: (2) Cannot walk (except for those who have been using walkers for = 12 weeks before screening and have been using walkers in the same way during the trial period); (3) There is active knee joint infection or medical conditions such as skin rupture, infection, or other factors affecting injection in the injection area; (4) Merge hip, knee, ankle, and multiple lower limb osteoarthritis; (5) Secondary knee osteoarthritis; (6) Damage to the knee joint caused by other reasons, or inflammatory pain diseases or diseases affecting the knee joint (including but not limited to: hemorrhagic arthritis, transient synovitis, femoral head epiphyseal spondylolisthesis, bone tuberculosis, bone tumors, hemorrhagic pigmented villonodular synovitis, purulent arthritis, rheumatoid arthritis, metabolic bone disease, psoriatic arthritis, gouty arthritis, symptomatic cartilage calcification, bone necrosis or active infection); (7) Other lower limb diseases that may interfere with the evaluation of knee joint efficacy, such as fibromyalgia, significant outward/inward deformity of the knee joint, ligament laxity, peripheral vascular diseases in the legs such as venous or lymphatic stasis, etc; (8) Meniscus injury or free body requiring surgery; (9) Individuals with hematological disorders or coagulation dysfunction that cannot be corrected; (10) Those who are taking antiplatelet or anticoagulant drugs and cannot stop taking them; (11) Individuals with severe diseases of important organs (cardiovascular system, lungs, liver, kidneys, and nervous system); (12) The liver function test results show that ALT or AST is greater than twice the upper limit of normal values; (13) Have a clear history of mental disorders, or a history of abuse or drug use of psychotropic substances; (14) Individuals who are allergic or intolerant to acetaminophen; (15) History of seafood allergy, chitosan allergy, or allergy to other materials involved in this experiment; (16) Pregnant, lactating women or those planning to become pregnant during the study period; (17) Individuals who have participated in any other clinical trials within one month prior to signing the informed consent form; (18) There are situations where other researchers have determined that it is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in WOMAC Pain Scale (VAS) from Baseline at Week 16; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in WOMAC score (VAS) compared to baseline at 5, 10, 16 and 28 weeks;Changes in overall assessment of patients at 5 weeks, 10 weeks, 16 weeks, and 28 weeks compared to baseline;Changes in overall physician evaluation compared to baseline at 5 weeks, 10 weeks, 16 weeks, and 28 weeks;Rescuing drug use during the trial period; | — |
Countries
China
Contacts
Public ContactWang Kunzheng
The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed