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Intra-articular injections of platelet-rich plasma for the treatment of osteoarthritis of the knee

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.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTb032190218
Enrollment
30
Registered
2020-02-19
Start date
2018-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoarthritis of the knee

Interventions

Using an aseptic technique, approximately 36 mL of venous blood were drawn from the antecubital vein in an effort to avoid irritation and trauma to the platelets. The blood was collected in four extra
BTI Biotechnology Institute, Vitoria, Spain) to separate the blood in each tube into the plasma, the buffy coat, and residual red blood cells (RBCs).Hereafter, the procedure was performed entirely ins

Sponsors

Yamazaki Masashi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Visual Analogue Scale for pain after 24 weeks from the start of treatment (at the time of the first injection) 2. The improvement rate of MRI Osteoarthritis Knee Score (MOAKS)

Countries

Japan

Contacts

Public ContactTomokazu Yoshioka

University of Tsukuba, Faculty of Medicine

yoshioka@md.tsukuba.ac.jp+81-29-853-3219

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026