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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017451
Receipt No. R000020230
Scientific Title Prospective clinical comparisons of semitendinosus versus semitendinosus and gracilis tendon autografts for anatomic double-bundle anterior cruciate ligament reconstruction.
Date of disclosure of the study information 2015/05/31
Last modified on 2015/05/07

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Basic information
Public title Prospective clinical comparisons of semitendinosus versus
semitendinosus and gracilis tendon autografts for anatomic double-bundle
anterior cruciate ligament reconstruction.
Acronym Comparisons of semitendinosus versus
semitendinosus and gracilis tendon autografts for anatomic double-bundle
ACL reconstruction
Scientific Title Prospective clinical comparisons of semitendinosus versus
semitendinosus and gracilis tendon autografts for anatomic double-bundle
anterior cruciate ligament reconstruction.
Scientific Title:Acronym Comparisons of semitendinosus versus
semitendinosus and gracilis tendon autografts for anatomic double-bundle
ACL reconstruction
Region
Japan

Condition
Condition ACL injury
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test the hypothesis that there are no significant differences between the semitendinosus tendon alone and the semitendinosus and gracilis tendon graft fashioning techniques concerning the knee stability and clinical outcome after anatomic double-bundle ACL reconstruction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical outcome
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 semitendinosus tendon
Interventions/Control_2 semitendinosus and gracilis tendons
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
13 years-old <=
Age-upper limit
59 years-old >=
Gender Male and Female
Key inclusion criteria ACL injury
Key exclusion criteria Patients with a bilateralACL injury, and Knee ostoarthritis were excluded from this study.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Kondo
Organization Hokkaido University Graduate School of Medicine
Division name Department of Advanced Therapeutic Research for Sports Medicine
Zip code
Address Kita-15 , Nishi-7 , Kita-ku, Sapporo, JAPAN
TEL 011-706-5935
Email eijik@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Kondo
Organization Hokkaido University Graduate School of Medicine
Division name Department of Advanced Therapeutic Research for Sports Medicine
Zip code
Address Kita-15 , Nishi-7 , Kita-ku, Sapporo, JAPAN
TEL 011-706-5935
Homepage URL
Email eijik@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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
2015 Year 05 Month 31 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 Completed
Date of protocol fixation
2004 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 12 Month 31 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
2015 Year 05 Month 07 Day
Last modified on
2015 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020230

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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