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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025287
Receipt No. R000028002
Scientific Title The effect of remnant preservation or synovial patch to cover the graft on clinical outcomes in double-bundle anterior cruciate ligament reconstruction: A prospective randomized controlled trial
Date of disclosure of the study information 2017/01/01
Last modified on 2016/12/15

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Basic information
Public title The effect of remnant preservation or synovial patch to cover the graft on clinical outcomes in double-bundle anterior cruciate ligament reconstruction: A prospective randomized controlled trial
Acronym Orthopedic Surgery, Tokyo Medical and Dental University Hospital
Scientific Title The effect of remnant preservation or synovial patch to cover the graft on clinical outcomes in double-bundle anterior cruciate ligament reconstruction: A prospective randomized controlled trial
Scientific Title:Acronym Orthopedic Surgery, Tokyo Medical and Dental University Hospital
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 evaluate the effect of remnant preservation or synovial patch to cover the graft on clinical outcomes in double-bundle anterior cruciate ligament reconstruction
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 No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 ACL volume remain equal to or more than 50 %:
ACL reconstruction without remnant preservation
Interventions/Control_2 ACL volume remain equal to or more than 50 %:
ACL reconstruction with remnant preservation
Interventions/Control_3 ACL volume remain less than 50 %:
ACL reconstruction without remnant preservation
Interventions/Control_4 ACL volume remain less than 50 %:
ACL reconstruction with remnant preservation and synovial patch
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Primary ACL reconstruction with double-bundlehhamstring tendon graft
Key exclusion criteria ACL reconstruction with any grafts except for hamstring tendon, bilateral ACL-injury, multiple ligament injury, past injured/surgical history of the knee
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Horie
Organization Tokyo Medical and Dental University
Division name Center for stem cell and regenerative medicine
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-4775
Email horie.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 Center for stem cell and regenerative 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 01 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
2016 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 Day
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
2016 Year 12 Month 15 Day
Last modified on
2016 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028002

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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