UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022376 |
|---|---|
| Receipt number | R000024987 |
| Scientific Title | In vivo elongation of cortical suspension device after double bundle ACL reconstruction -A three dimensional MRI and CT study |
| Date of disclosure of the study information | 2016/05/20 |
| Last modified on | 2020/12/09 23:58:26 |
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Basic information
Public title
In vivo elongation of cortical suspension device after double bundle ACL reconstruction
-A three dimensional MRI and CT study
Acronym
In vivo elongation of cortical suspension device after double bundle ACLR
Scientific Title
In vivo elongation of cortical suspension device after double bundle ACL reconstruction
-A three dimensional MRI and CT study
Scientific Title:Acronym
In vivo elongation of cortical suspension device after double bundle ACLR
Region
| Japan |
Condition
Condition
Anterior cruciate ligament injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To address this, we propose a study where two types of cortical suspension devices are to be compared in terms of graft displacement after double bundle ACL reconstruction by examining graft position with the use of three dimensional MRI and CT analysis. Devices to be compared are Endbutton CL and Tightrope.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjects will receive three-dimentional, proton emphasis fat suppression MR images(132 slices) captured by 3.0T GE within a week after reconstruction, at 3, 6, and 12 months post op. CT data will be collect within a week after surgery and 12 months after surgery. Graft position is to be assessed using MRI data by imaging software where slices that run through the axis of femoral tunnel are reconstructed and distance between bottom of bone socket and the tip of graft are measured.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Device,equipment |
Interventions/Control_1
end button CL
Interventions/Control_2
tight rope
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
| 15 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient corresponding to all of the following conditions of interest
Grade2 or 3 in Lachman's test
Lateral pivot shift test is positive and, visualization of the ACL torn on MRI examination.
knee joint range of motion(flextion) is 120 degree or more
Patients enforce the range of motion training and muscle strength maintenance training preoperative.
the age less than 50 years from the epiphyseal line closed
Key exclusion criteria
The patients who falls under any of the following conditions are not included
Reinjury
Patients do not hope to sports activities and choose conservative treatment
Patients who wish to surgery with autologous tendon other than hamstring tendon
Patients with a medical disease that movement restriction has been instructed
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | takahisa |
| Middle name | |
| Last name | sasho |
Organization
chiba university hospital
Division name
orthopedics
Zip code
260-8677
Address
1-8-1,inohana,chiba city chuoku,chiba
TEL
043-222-7171
ys9964@gmail.com
Public contact
Name of contact person
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Ono |
Organization
chiba university hospital
Division name
orthopedics
Zip code
260-8677
Address
1-8-1,inohana,chiba city chuoku,chiba
TEL
043-222-7171
Homepage URL
y.ono@kbe.biglobe.ne.jp
Sponsor or person
Institute
chiba university hospital
Institute
Department
Personal name
Funding Source
Organization
arthrex japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
USA
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital Clinical Research Center
Address
1-8-1 Inohana Chuo-ku Chiba 260-8677, JAPAN
Tel
043-226-2734
chibacrc@mac.com
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
| 2016 | Year | 05 | Month | 20 | 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
| 2016 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 19 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 28 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 17 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 20 | Day |
Last modified on
| 2020 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024987
