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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

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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

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

Region
Japan

Condition
Condition Anterior cruciate ligament injury
Classification by specialty
Orthopedics
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
Maneuver
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
14 years-old <=
Age-upper limit

Not applicable
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
1st name
Middle name
Last name Hideyuki Koga
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
Email koga.orj@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masafumi Horie
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
Email 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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 07 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
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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
2025 Year 03 Month 31 Day
Date trial data considered complete
2025 Year 03 Month 31 Day
Date analysis concluded
2026 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 06 Month 02 Day
Last modified on
2017 Year 06 Month 02 Day


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


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