UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036496 |
|---|---|
| Receipt number | R000041585 |
| Scientific Title | Effectiveness and Safety of Platelet-Rich Plasma Injection for Achilles Tendon Rupture Repair |
| Date of disclosure of the study information | 2019/04/13 |
| Last modified on | 2019/04/13 10:03:50 |
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Basic information
Public title
Effectiveness and Safety of Platelet-Rich Plasma Injection for Achilles Tendon Rupture Repair
Acronym
PRP for ATRR
Scientific Title
Effectiveness and Safety of Platelet-Rich Plasma Injection for Achilles Tendon Rupture Repair
Scientific Title:Acronym
PRP for ATRR
Region
| Japan |
Condition
Condition
Achilles tendon rupture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effectiveness and safety of PRP for Achilles tendon rupture repair
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bilateral heel rise test
Key secondary outcomes
1)Single heel rise test
2)clinical score
3)MRI findings
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Injection of PRP to suture site of Achilles tendon 3 weeks after surgery.
Interventions/Control_2
Injection of saline to suture site of Achilles tendon 3 weeks after surgery.
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1) A patient with Achilles tendon rupture diagnosed based on physical and MRI findings
2) Primary injury
3) Single leg injury
4) Patients who would like to receive surgery
Key exclusion criteria
1) A patient who does not agree with non-smoking
2) Diabetes, malignant cancer, and autoimmune disease
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Youichi |
| Middle name | |
| Last name | Yasui |
Organization
Teikyo University School of Medicine
Division name
Orthopaedic department
Zip code
173-8605
Address
2-11-1, Kaga, Itabashi, Tokyo
TEL
03-3964-4097
youichi_yasui_41@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Youichi |
| Middle name | |
| Last name | Yasui |
Organization
Teikyo University School of Medicine
Division name
Orthopaedic department
Zip code
173-8605
Address
2-11-1, Kaga, Itabashi, Tokyo
TEL
03-3964-4097
Homepage URL
youichi_yasui_41@yahoo.co.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Teikyo University
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
Teikyo University Review Board
Address
2-11-1, Kaga, Itabashi, Tokyo
Tel
03-3964-7256
turb-office@teikyo-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
CNCD3-30001
Org. issuing International ID_1
CONCIDE
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 13 | 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
| 2018 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 13 | Day |
Last modified on
| 2019 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041585
