UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014219 |
|---|---|
| Receipt number | R000016561 |
| Scientific Title | Utility of a new developed motion capture with infrared camera system in ACL-insufficient knees. |
| Date of disclosure of the study information | 2014/06/10 |
| Last modified on | 2015/06/16 11:05:53 |
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Basic information
Public title
Utility of a new developed motion capture with infrared camera system in ACL-insufficient knees.
Acronym
Utility of a new developed motion capture with infrared camera system
Scientific Title
Utility of a new developed motion capture with infrared camera system in ACL-insufficient knees.
Scientific Title:Acronym
Utility of a new developed motion capture with infrared camera system
Region
| Japan |
Condition
Condition
ACL-insufficient knees
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study are to compare our newly noninvasive motion capture with infrared camera system (MCICS) with the standard validated commercial navigation system in terms of reliability and repeatability of the rotational kinematics in the ACL-insufficient knee, and to validate the utility of our MCICS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the rotational instability in the knee
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 10 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) less than 30 yo
2) unilateral ACL injury
3) Obtaining of informed consent
Key exclusion criteria
1) accompaning of meniscal injury and ligament injury more than 2 degrees
2) The person can not have the radiolographic examination or MRI
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiichi Nakamura |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Orthopaedic Surgery,
Zip code
Address
1-1-1, Chuoku, Honjo, Kumamoto-City, Kumamoto, 860-8556, JAPAN
TEL
096-373-5226
h@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiichi Nakamura |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-1-1, Chuoku, Honjo, Kumamoto-City, Kumamoto, 860-8556, JAPAN
TEL
096-373-5226
Homepage URL
h@kumamoto-u.ac.jp
Sponsor or person
Institute
Faculty of Life Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Faculty of Life Sciences, Kumamoto 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
| 2014 | Year | 06 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
The injured knees in all patients were evaluated during the pivot shift test by a single surgeon before reconstruction under anesthesia using our MCICS. During the pivot-shift test, the starting angle of the pivot-shift phenomenon and tibial rotational angle defined as the amount of rotational angle when an anterior subluxation and a subsequent reduction in the tibial plateau from the femoral condyle were extracted from the kinematics data recorded by MCICS. The verification of the MCICS was analyzed using the interclass correlation coefficient (ICC) for those values between Navigation system. A p-value less than 0.05 were considered to be statistically significant.
Management information
Registered date
| 2014 | Year | 06 | Month | 10 | Day |
Last modified on
| 2015 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016561
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
