UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030963 |
|---|---|
| Receipt number | R000035357 |
| Scientific Title | MRI Evaluation after Achilles Tendon Repair by Percutaneous Achilles tendon Repair System(PARS) |
| Date of disclosure of the study information | 2018/01/24 |
| Last modified on | 2024/01/31 12:48:12 |
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Basic information
Public title
MRI Evaluation after Achilles Tendon Repair by
Percutaneous Achilles tendon Repair System(PARS)
Acronym
MRI Evaluation after Achilles Tendon Repair by
PARS
Scientific Title
MRI Evaluation after Achilles Tendon Repair by
Percutaneous Achilles tendon Repair System(PARS)
Scientific Title:Acronym
MRI Evaluation after Achilles Tendon Repair by
PARS
Region
| Japan |
Condition
Condition
Acute Achilles tendon rupture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we evaluate MRI after achilles
tendon repair by Percutaneous Achilles tendon Repair System(PARS).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MRI of Achilles tendon: preoperative, POM1, POM2, POM3
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
MRI
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
| 1 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who had achilles tendon repair surgery by PARS within 1 week after injury
Key exclusion criteria
Patients who do not know the situation of the injury
Patients who have other trauma except achilles tendon rupture
Patients who have SSI after surgery
Patients who can not take MRI
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tetsu |
| Middle name | |
| Last name | Aizawa |
Organization
Teine Keijinkai Hospital
Division name
Orthopedic surgery
Zip code
0068555
Address
12-1-40, Maeda1-jo, Teine-ku, Sappro, Hokkaido
TEL
0116818111
aizawa-te@keijinkai.or.jp
Public contact
Name of contact person
| 1st name | Tetsu |
| Middle name | |
| Last name | Aizawa |
Organization
Teine Keijinkai Hospital
Division name
Orthopedic surgery
Zip code
0068555
Address
12-1-40, Maeda1-jo, Teine-ku, Sappro, Hokkaido
TEL
0116818111
Homepage URL
aizawa-te@keijinkai.or.jp
Sponsor or person
Institute
Teine Keijinkai Hospital
Institute
Department
Personal name
Funding Source
Organization
Teine Keijinkai Hospital
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
Teine Keijinkai Hospital
Address
12-1-40, Maeda1-jo, Teine-ku, Sappro, Hokkaido
Tel
0116818111
aizawa-te@keijinkai.or.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
| 2018 | Year | 01 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 24 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035357
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
