UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017451 |
|---|---|
| Receipt number | 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 15:25:07 |
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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
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
eijik@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020230
