Intra-articular injections of platelet-rich plasma for the treatment of osteoarthritis of the knee: a randomized, double-blind, placebo-controlled phase 2 clinical trial. - PRP treatment for osteoarthritis of the knee.

Yamazaki Masashi0 个研究点目标入组 30 人开始时间: 2020年2月19日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Patients who meet the diagnostic criteria for osteoarthritis of the knee
•2. Male and female between 20 years old more and less than 80 years old at the time of informed consent
•3. With a history of chronic (for at least 3 months) knee joint pain more than 35-mm on 0- to 100-mm visual analogue scale
•4. Radiographically documented grades 1-3 osteoarthritis of the knee, grade according to the Kellgren-Lawrence radiographic classification scale
•5. With hydrarthrosis or bone marrow lesion or synovitis
•6. Requiring infiltration in monolateral knee
•7. Possibility for observation during follow-up period of 24 weeks

•1. BMI less than 18.5
•2. BMI more than 30
•3. Suffering from polyarticular disease
•4. Valgus knee and varus knee more than 10 degree in X-ray
•5. Previous knee arthroscopy within 6 months
•6. HA or steroid intra-articular infiltration within last 1 month
•7. Past history of infectious disease
•8. Skin disease in knee
•9. Compromised host
•10. Systemic autoimmune disease
•11. Anemia with hemoglobin under 9.0 g/dl
•12. Blood disorders
•13. Treatment with anticoagulant drugs (Aspirin, Warfarin)
•14. Having undergone treatment with steroids during 3 months before inclusion in this study
•15. Treatment with NSAIDs during 2 weeks before its inclusion in this study
•16. Patients who had malignancy during 5 years before inclusion in this study
•17. Patients who cannot have a consent with document
•18. Patients whom the doctor has determined that it is not suitable for this clinical study

发起方

Yamazaki Masashi