UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017932 |
|---|---|
| Receipt number | R000006393 |
| Scientific Title | Surgical tretment augumented by autologous platelet-rich plasma for osteonecrosis or nonunion in the orthopaedic field |
| Date of disclosure of the study information | 2015/06/20 |
| Last modified on | 2015/06/16 23:12:09 |
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Basic information
Public title
Surgical tretment augumented by autologous platelet-rich plasma for osteonecrosis or nonunion in the orthopaedic field
Acronym
Surgical tretment augumented by autologous platelet-rich plasma for osteonecrosis or nonunion in the orthopaedic field
Scientific Title
Surgical tretment augumented by autologous platelet-rich plasma for osteonecrosis or nonunion in the orthopaedic field
Scientific Title:Acronym
Surgical tretment augumented by autologous platelet-rich plasma for osteonecrosis or nonunion in the orthopaedic field
Region
| Japan |
Condition
Condition
Osteonecrosis or nonunion in the orthopaedic field
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety or efficacy of surgical tretment augumented by autologous PRP for the treatment of osteonecrosis or nonunion in the orthopaedic field
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The percentage of the united bone is detectd by the CT one month after the administration of autologus PRP
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Surgical treatment for the osteonecrosis or nonunion in the orthopaedic field is augumented by the administration of autologus PRP(3-5cc)
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
In case of osteonecrosis,
the patient who diagnosed as
osteonecrosis by MRI
In case of nonunion,
the patient who have had unhealed
fracture for more than 3 months
The patient who accepts our informed consent
Key exclusion criteria
The patient who is pregnant
The patient who has allergy for thrombin
The patient who has hematologic disease and/or tendency to bleed
The patient who shows anemia or thrombocytepenia
The patient who can't understand what we ask
The patient who can't communicate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Sunagawa |
Organization
Hiroshima University
Division name
Dept. of Locomotor System Dysfunction, Applied Life Sciences, Institute of Biomedical & Health Science
Zip code
Address
1-2-3, Kasumi, Minami-ku, hiroshima
TEL
082-257-5233
torusuna@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rikuo Shinomiya |
Organization
Hiroshima University Hospital
Division name
Department of orthopaedic surgery
Zip code
Address
1-2-3, Kasumi, Minami-ku, hiroshima
TEL
082-257-5233
Homepage URL
shinomi0123@yahoo.co.jp
Sponsor or person
Institute
Department of orthopaedic surgery, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Devision of regeneration and medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
| 2015 | Year | 06 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 16 | Day |
Last modified on
| 2015 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006393
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
