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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002078
Receipt No. R000002533
Scientific Title Open-label trial of autologous buffered plate-rich plasma for evaluating efficacy on soft tissue injury in orthopaedic field
Date of disclosure of the study information 2009/08/01
Last modified on 2017/06/20

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Basic information
Public title Open-label trial of autologous buffered plate-rich plasma for evaluating efficacy on soft tissue injury in orthopaedic field
Acronym Treatment of soft tissue injury in orthopaedic field with autologous buffered platelet-rich plasma
Scientific Title Open-label trial of autologous buffered plate-rich plasma for evaluating efficacy on soft tissue injury in orthopaedic field
Scientific Title:Acronym Treatment of soft tissue injury in orthopaedic field with autologous buffered platelet-rich plasma
Region
Japan

Condition
Condition Soft tissue injury in orthopaedic field
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy and safety of autologous plate-rich plasma (PRP) injection on patients with chronic tendinitis, muscle injury, ligament and tendon injury, peripheral nerve injury at 4, 8, 12 weeks after injection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Compare the pain score before and after 12 weeks the local injection of autologous PRP
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment Maneuver
Interventions/Control_1 Local injection of PRP
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuo Ochi
Organization Hiroshima University
Division name Department of Orthopaedic Surgery
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima-City, Hiroshima 734-8551, Japan
TEL 082-257-5230
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nobuo Adachi
Organization Hiroshima University
Division name Department of Orthopaedic Surgery
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima-City, Hiroshima 734-8551, Japan
TEL 082-257-5233
Homepage URL
Email nadachi@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital Department of Orthopaedic Surgery
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2009 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2011 Year 11 Month 01 Day
Date of closure to data entry
2011 Year 11 Month 01 Day
Date trial data considered complete
2011 Year 11 Month 01 Day
Date analysis concluded
2012 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 06 Month 15 Day
Last modified on
2017 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002533

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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