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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000027605 |
Receipt No. | R000031288 |
Scientific Title | A comparison of clinical outcomes after ACL reconstruction using patellar tendon versus hamstring autograft |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2017/06/02 |
Basic information | ||
Public title | A comparison of clinical outcomes after ACL reconstruction using patellar tendon versus hamstring autograft | |
Acronym | A comparison of BTB vs STG for ACLR
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Scientific Title | A comparison of clinical outcomes after ACL reconstruction using patellar tendon versus hamstring autograft | |
Scientific Title:Acronym | A comparison of BTB vs STG for ACLR
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Region |
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Condition | ||
Condition | Anterior cruciate ligament injury | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of the study is to compare the clinical outcomes in anterior cruciate ligament reconstruction between bone-patellar tendon-bone (BTB) versus hamstrings tendon (STG) grafts. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Stability of the knee joint |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | NO |
Concealment | Numbered container method |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | ACL reconstruction with bone-patellar tendon-bone(BTB) | |
Interventions/Control_2 | Double-bundle ACL reconstruction with hamstrings(STG) | |
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 | Primary ACL reconstruction for isolated ACL injury | |||
Key exclusion criteria | Bilateral ACL-injury, multiple ligament injury, and past injured/surgical history of the knee | |||
Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tokyo Medical and Dental University | ||||||
Division name | Department of Joint Surgery and Sports Medicine | ||||||
Zip code | |||||||
Address | 1-5-45 Yushima, Bunkyo-ku, Tokyo | ||||||
TEL | 03-5803-4020 | ||||||
koga.orj@tmd.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Tokyo Medical and Dental University | ||||||
Division name | Department of Joint Surgery and Sports Medicine | ||||||
Zip code | |||||||
Address | 1-5-45 Yushima, Bunkyo-ku, Tokyo | ||||||
TEL | 03-5803-4775 | ||||||
Homepage URL | |||||||
horie.orj@tmd.ac.jp |
Sponsor | |
Institute | Tokyo Medical and Dental University |
Institute | |
Department |
Funding Source | |
Organization | Tokyo Medical and Dental University |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
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Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 | |
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Results Delayed | |
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Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
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Other | |
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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=R000031288 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |