UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002078 |
|---|---|
| Receipt number | 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 19:11:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
nadachi@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital Department of Orthopaedic Surgery
Institute
Department
Personal name
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
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
Value
https://center6.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 |
