Intra-articular platelet-rich plasma injections for the patients with osteoarthritis of the knee in the Japanese population: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

Intra-articular platelet-rich plasma injections for the patients with osteoarthritis of the knee in the Japanese population: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial - Platelet-rich plasma injections for the patients with osteoarthritis of the knee in the Japanese population

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000034517

Enrollment

Registered

2018-11-01

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

Intra-articlar injections: Platelet-rich plasma derived from autologous peripheral blood Intra-articlar injections: Saline

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 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 2. Radiographically documented grades 1-3 osteoarthritis of the knee, grade according to the Kellgren-Lawrence radiographic classification scale 3. With hydrarthrosis or bone marrow lesion or synovitis 4. Requiring infiltration in monolateral knee 5. Possibility for observation during follow-up period

Exclusion criteria

Exclusion criteria: 1. BMI less than 18.5 2. BMI more than 25 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

Measure	Time 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

Measure	Time 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 Div. of Regenerative Med. for Musculoskeletal System, Dep. of Orthop. Surgery, Faculty of Medicine

yoshioka@md.tsukuba.ac.jp029-853-3219

Outcome results

None listed

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