Knee osteoarthritis
Conditions
Interventions
Treatment group:Platelet-rich plasma preparation kit
Control group:Disposable platelet-rich plasma preparers
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age >=40 years old and =70 years old, gender is not limited; 2.Diagnosed with knee osteoarthritis, Kellgren-Lawrence grade I ~ III, intended to be treated with platelet-rich plasma injection into knee cavity; 3.WOMAC score >=40 points; 4.The subject and/or his/her guardian can understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with severe heart, liver, lung, kidney failure, severe nervous system disease, severe cardiovascular disease, malignant tumor, systemic infection or uncontrolled local infection, sepsis; 2.Patients with bleeding disorders (such as hemophilia, vitamin K deficiency, etc.), disorders with abnormal platelet function (such as giant platelet syndrome, thrombocytopathia, storage pool disease, etc.), or other blood-related diseases that researchers have judged unsuitable for platelet-rich plasma collection; 3.Aspartate aminotransferase (AST)or alanine aminotransferase (ALT)> 2.5 times the upper limit of normal value; 4.Severe coagulation dysfunction (PT, APTT or INR > 1.5 times the upper normal limit); 5.Hemoglobin <=110g/L, platelet count <=120×10^9 /L; 6.History of knee surgery within 6 months before screening or planned knee surgery within 6 months after enrollment; 7.Received other intra-articular injections within 3 months before screening of the affected knee; 8.History of systemic glucocorticoid therapy within 14 days before or during the screening period, anticoagulation or antiplatelet therapy within 7 days before or during the screening period; 9.Pregnant or lactating women; 10.Have participated in or are participating in other interventional clinical trials within 28 days prior to screening; 11.Other situations in which the investigator considers that they should not participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC score 12 weeks after initial injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| WOMAC score at 24 weeks after initial injection;IKDC score 12 weeks and 24 weeks after the first injection;Product performance evaluation; | — |
Countries
China
Contacts
Public ContactYuan Ting
Shanghai Sixth People's Hospital
Outcome results
None listed