UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030322 |
|---|---|
| Receipt number | R000034626 |
| Scientific Title | Effectiveness of braided polyblend suture for ACL reconstruction |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2017/12/08 20:06:56 |
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Basic information
Public title
Effectiveness of braided polyblend suture for ACL reconstruction
Acronym
Effectiveness of braided polyblend suture for ACL reconstruction
Scientific Title
Effectiveness of braided polyblend suture for ACL reconstruction
Scientific Title:Acronym
Effectiveness of braided polyblend suture for ACL reconstruction
Region
| Japan |
Condition
Condition
ACL injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness of braided polyblend suture for augmentation of ACL graft
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
stability of knee joint
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
group of braided polyblend suture
Interventions/Control_2
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
| 12 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients planned for ACL surgery
Key exclusion criteria
patients received previous surgery
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiji Tensho |
Organization
Shinshu unversity
Division name
orthopedic surgery
Zip code
Address
3-1-1 Asahi Matsumoto City, Nagano, Japan,
TEL
0263-37-2659
kten@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiji Tensho |
Organization
Shinshu unversity
Division name
orthopedic surgery
Zip code
Address
3-1-1 Asahi Matsumoto City, Nagano, Japan,
TEL
0263-37-2659
Homepage URL
kten@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu unversity
Institute
Department
Personal name
Funding Source
Organization
Shinshu 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
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
| 2018 | 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
| 2017 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 09 | 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
| 2017 | Year | 12 | Month | 08 | Day |
Last modified on
| 2017 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034626
