UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046918 |
|---|---|
| Receipt number | R000053530 |
| Scientific Title | PRP treatment combined with tendon repair and early functional rehabilitation for Achilles tendon rupture in athletes |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2024/08/19 12:18:57 |
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Basic information
Public title
PRP treatment combined with tendon repair for Achilles tendon rupture in athletes
Acronym
PRP treatment for Achilles tendon rupture in athletes
Scientific Title
PRP treatment combined with tendon repair and early functional rehabilitation for Achilles tendon rupture in athletes
Scientific Title:Acronym
PRP treatment combined with tendon repair for Achilles tendon rupture in athletes
Region
| Japan |
Condition
Condition
Achilles tendon rupture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to prospectively investigated the clinical results of PRP treatment combined with postoperative early functional rehabilitation for Achilles tendon rupture in athletes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rate of return to sports until 6 months after intervention
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
| Other |
Interventions/Control_1
Tendon repair, PRP(3 ml) injection, tendon biopsy
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.patients who is scheduled to receive operative treatment for Achilles tendon rupture
2.athletes
3.patients who is scheduled to receive early functional rehabilitation after operation
4.patients aged sixteen and over and patients aged under sixty-five
Key exclusion criteria
1.patients who received steroid therapy
2.re-rupture case
3.patients who previously received operative treatment of Achilles tendon
4.patients who could not undergo MRI examination
5.patients who is judged unsuitable by investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshito |
| Middle name | |
| Last name | Yasuda |
Organization
Osaka Medical and Pharmaceutical University
Division name
Faculty of nursing
Zip code
569-0095
Address
7-6, Hatchonishi-machi, takatsuki City, Osaka, Japan
TEL
072-684-7267
toshito.yasuda@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Toshito |
| Middle name | |
| Last name | Yasuda |
Organization
Osaka Medical and Pharmaceutical University
Division name
Faculty of nursing
Zip code
569-0095
Address
7-6, Hatchonishi-machi, takatsuki City, Osaka, Japan
TEL
072-684-7267
Homepage URL
toshito.yasuda@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports, science and technology-Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee, Osaka Medical and Pharmaceutical University
Address
2-7, Daigaku-machi, takatsuki City, Osaka 569-8686, Japan
Tel
072-683-1221
rinri@ompu.ac.jp
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
| 2022 | Year | 03 | 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
3
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2022 | Year | 02 | Month | 15 | Day |
Last modified on
| 2024 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053530
