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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000035114 |
Receipt No. | R000040022 |
Official scientific title of the study | 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 |
Basic information | ||
Official scientific title of the study | Long-term effectiveness and safety of an autologous leukocyte-platelet-rich plasma injection( L-PRP) for the human musculoskeletal injuries. | |
Title of the study (Brief title) | Long-term effectiveness and safety of an autologous leukocyte-platelet-rich plasma injection( L-PRP) for the human musculoskeletal injuries. | |
Region |
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Condition | ||
Condition | the enthesitis, enthesopathy and ligament injuries | |
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 20 |
Research contact person | |
Name of lead principal investigator | Hiroki Funasaki |
Organization | Department of Sports and Wellness Clinic, The Jikei University School of Medicine |
Division name | Department of Sports and Wellness Clinic |
Address | 3-25-8 Nishishinbashi Minato-ku Tokyo-to |
TEL | 03-3433-1111 |
ms05yusukemurayama@gmail.com |
Public contact | |
Name of contact person | Yusuke Murayama |
Organization | Department of Sports and Wellness Clinic, The Jikei University School of Medicine |
Division name | Department of Sports and Wellness Clinic |
Address | 3-25-8 Nishishinbashi Minato-ku Tokyo-to |
TEL | 03-3433-1111 |
Homepage URL | |
ms05yusukemurayama@gmail.com |
Sponsor | |
Institute | Department of Sports and Wellness Clinic, The Jikei University School of Medicine |
Institute | |
Department |
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) |
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 |
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Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
URL releasing results | |
Results | |
Other related information | It is before starting examination today, third December 2018. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040022 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |