Intra-articular injections of platelet-rich plasma for the treatment of osteoarthritis of the knee
- Conditions
- osteoarthritis of the knee
- Registration Number
- JPRN-jRCTb032190218
- Lead Sponsor
- Yamazaki Masashi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The improvement rate of WOMAC (Western Ontario and McMaster Universities Osteoarthritis) score in comparison between 24 weeks after the start of treatment and before treatment.
- Secondary Outcome Measures
Name Time Method 1. Visual Analogue Scale for pain after 24 weeks from the start of treatment (at the time of the first injection)<br>2. The improvement rate of MRI Osteoarthritis Knee Score (MOAKS)