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

UMIN ID: UMIN000002078

Registered date:01/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Soft tissue injury in orthopaedic field
• Date of first enrollment: 2009/08/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Local injection of PRP

Outcome(s)

• Primary Outcome: Compare the pain score before and after 12 weeks the local injection of autologous PRP
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Hiroshima University Hospital Department of Orthopaedic Surgery
• Secondary Sponsor: None
• Source(s) of Monetary Support: none,None