UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011812 |
|---|---|
| Receipt number | R000013788 |
| Scientific Title | Clinical study of patella axis radiography of positioning indicator at the tibial tuberosity |
| Date of disclosure of the study information | 2013/09/19 |
| Last modified on | 2015/01/15 17:24:16 |
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Basic information
Public title
Clinical study of patella axis radiography of positioning indicator at the tibial tuberosity
Acronym
Development to standard radiographic method of a new skyline view
Scientific Title
Clinical study of patella axis radiography of positioning indicator at the tibial tuberosity
Scientific Title:Acronym
Development to standard radiographic method of a new skyline view
Region
| Japan |
Condition
Condition
Knee joint pain
Classification by specialty
| Orthopedics | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development to standard radiographic method of a new skyline view.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
This method an angle of incidence is 19.2 degrees ,not dependent bending angle, age and sex
Key secondary outcomes
There are supplied to more precise and true axis image by new skyline view radiographic method.
Base
Study type
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
The radiographic method of new irradiation angle.
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
| 16 | years-old | <= |
Age-upper limit
| 86 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were ordered by orthpaedic surgeons.
Key exclusion criteria
Total Knee Joint Replacement surgery.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Koike |
Organization
National Defense Medical College Hp
Division name
Radiological Center
Zip code
Address
Namiki3-2.Tokorozawa-c.Saitama-Prif.
TEL
04-2995-1511
koike@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Koike |
Organization
National Defense Medical College Hp
Division name
Radiological Center
Zip code
Address
Namiki3-2.Tokorozawa-c.Saitama-Prif.
TEL
04-2995-1511
Homepage URL
koike@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College Hp
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
防衛医科大学校病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 19 | 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 | 08 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | 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
| 2013 | Year | 09 | Month | 19 | Day |
Last modified on
| 2015 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013788
