MedPath

Safety and efficacy of intra-articular injections of platelet-rich plasma for the treatment of osteoarthritis of the knee in the Japanese populatio

Phase 2
Conditions
Osteoarthritis of the knee
Registration Number
JPRN-UMIN000011829
Lead Sponsor
niversity of Tsukuba Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
10
Inclusion Criteria

Not provided

Exclusion Criteria

1. Requiring infiltration in both knees 2. BMI more than 33 3. Suffering from polyarticular disease 4. Previous knee arthroscopy within last year 5. HA or steroid intra-articular infiltration within last 3 months 6. Past history of infectious disease 7. Compromised host 8. Systemic autoimmune disease 9. Anemia with hemoglobin under 10g/dl 10. Blood disorders 11. Treatment with anticoagulant drugs (Aspirin, Warfarin) 12. Having undergone treatment with steroids during 3 months before inclusion in this study 13. Treatment with NSAIDs during 2 weeks before its inclusion in this study 14. Patients who had malignancy during 5 years before inclusion in this study 15. Patients who do not have a voluntary consent capacity 16. Patients who cannot have a consent with document 17. Patients whom the doctor has determined that it is not suitable for this clinical study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Adverse events during the treatment and follow-up period. 1. Shock 2. Pain and stiffness 3. Swelling 4. Local heat
Secondary Outcome Measures
NameTimeMethod
1. The percentage of patients having a 50% decrease in the summed score for the Visual Analogue Scale from baseline to week 24. 2. Serum hyaluronic acid concentration rate before and after treatment 3. Improvement of felction and extension angle of the knee 4. Improvement rate of Japanese Knee Osteoarthritis Measure 5. Improvement of Japanese Orthopaedics Association score
© Copyright 2025. All Rights Reserved by MedPath