UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035114 |
|---|---|
| Receipt number | R000040022 |
| Scientific Title | Long-term effectiveness and safety of an autologous leukocyte-platelet-rich plasma injection( L-PRP) for the human musculoskeletal injuries. |
| Date of disclosure of the study information | 2018/12/03 |
| Last modified on | 2018/12/03 14:20:07 |
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Basic information
Public title
Long-term effectiveness and safety of an autologous leukocyte-platelet-rich plasma injection( L-PRP) for the human musculoskeletal injuries.
Acronym
Long-term effectiveness and safety of an autologous leukocyte-platelet-rich plasma injection( L-PRP) for the human musculoskeletal injuries.
Scientific Title
Long-term effectiveness and safety of an autologous leukocyte-platelet-rich plasma injection( L-PRP) for the human musculoskeletal injuries.
Scientific Title:Acronym
Long-term effectiveness and safety of an autologous leukocyte-platelet-rich plasma injection( L-PRP) for the human musculoskeletal injuries.
Region
| Japan |
Condition
Condition
the enthesitis, enthesopathy and ligament injuries
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of long-term effectiveness and safety of an autologous leukocyte-platelet-rich plasma injection( L-PRP) for the enthesitis, enthesopathy and ligament injuries.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain, tenderness, Visual Analog Scale and Scale of returning to play after 1, 4, 8, 12 weeks from the injection
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient who has the enthesis, enthesitis and ligament injuries.
The patient who consents
The patient who does not have infections
Key exclusion criteria
The patient who has infections
The patient who has fever over 37.0 degrees
The patient who has a wound
The patient who has oral treatment
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Funasaki |
Organization
Department of Sports and Wellness Clinic, The Jikei University School of Medicine
Division name
Department of Sports and Wellness Clinic
Zip code
Address
3-25-8 Nishishinbashi Minato-ku Tokyo-to
TEL
03-3433-1111
ms05yusukemurayama@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Murayama |
Organization
Department of Sports and Wellness Clinic, The Jikei University School of Medicine
Division name
Department of Sports and Wellness Clinic
Zip code
Address
3-25-8 Nishishinbashi Minato-ku Tokyo-to
TEL
03-3433-1111
Homepage URL
ms05yusukemurayama@gmail.com
Sponsor or person
Institute
Department of Sports and Wellness Clinic, The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Sports and Wellness Clinic, The Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 12 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 12 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It is before starting examination today, third December 2018.
Management information
Registered date
| 2018 | Year | 12 | Month | 03 | Day |
Last modified on
| 2018 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040022
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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