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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000030963 |
Receipt No. | 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 | 2019/07/27 |
Basic information | ||
Public title | MRI Evaluation after Achilles Tendon Repair by
Percutaneous Achilles tendon Repair System(PARS) |
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Acronym | MRI Evaluation after Achilles Tendon Repair by
PARS |
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Scientific Title | MRI Evaluation after Achilles Tendon Repair by
Percutaneous Achilles tendon Repair System(PARS) |
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Scientific Title:Acronym | MRI Evaluation after Achilles Tendon Repair by
PARS |
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Region |
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Condition | ||
Condition | Acute Achilles tendon rupture | |
Classification by specialty |
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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
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Teine Keijinkai Hospital |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
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 |
Other | |
Other related information |
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=R000035357 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |