UMIN-CTR Clinical Trial

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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