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Open-label trial of autologous buffered plate-rich plasma for evaluating efficacy on soft tissue injury in orthopaedic field

Open-label trial of autologous buffered plate-rich plasma for evaluating efficacy on soft tissue injury in orthopaedic field - Treatment of soft tissue injury in orthopaedic field with autologous buffered platelet-rich plasma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002078
Enrollment
50
Registered
2009-08-01
Start date
2009-08-01
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

Soft tissue injury in orthopaedic field

Interventions

Local injection of PRP

Sponsors

Hiroshima University Hospital Department of Orthopaedic Surgery
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients that have tendinitis for 3 months and pain with more than 50mm/100mm at VAS scale 2) Patients that have the pain with more than 50mm/100mm at VAS scale or joint instability for more than 1 month after muscle, tendon and ligament injury. 3) Patients that have the pain or numbness derived from the peripheral nerve disorder for more than 3 months. 4) Patients with the pain or numbness that did not improve by conventional treatments. 5) The age is no object. 6) In or out patient is no object. 7) Patients that have written permission to join this trial.

Exclusion criteria

Exclusion criteria: 1) Patients with pregnancy. 2) Patients with the history of anemia. 3) Patients with the history of coagulopathy. 4) Patients who have been diagnosed as reticulopathy. 5) Patients with the systemic disease such as diabetes mellitus, rheumatoid arthritis and hepatitis 6) Patients with noncooperativity or neurological deficit not to obey the instructions, and who is expected not to come the outpatients' clinic for follow-up examination. 7) Patients who have taken surgical treatment for disease of this trial indication. 8) Patients with hypothyroidism. 9) Patients with the history of hematopoietic disease. 10) The patient who shows hemoglobin value out of the next range: 12.0-18.0g/dL. 11) The patient who shows hematocrit value out of the next range: 40.0 ~ 52.0%. 12) The patient who shows platelet numerical value out of the next range: 150 ~ 400x103/uL. 13) Patients who applied or plan to apply the compensation program for industrial accident, or who fight a trial or plan to trial due to the elbow pain. 14) Patients who have been diagnosed as arthropathy or fracture by plain radiogram. 15) Patients who is difficult to understand the question by disturbance of consciousness, disorientation and dementia. 16) Patients who cannot make themselves understood by motor disturbance or dificiency of language function.

Design outcomes

Primary

MeasureTime frame
Compare the pain score before and after 12 weeks the local injection of autologous PRP

Secondary

MeasureTime frame
Compare the pain score (VAS) before and after 4 and 8 weeks the local injection of PRP, and compare the clinical score before and after 4, 8 and 12 weeks the local injection of PRP

Countries

Japan

Contacts

Public ContactNobuo Adachi

Hiroshima University Department of Orthopaedic Surgery

nadachi@hiroshima-u.ac.jp082-257-5233

Outcome results

None listed

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