UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028903 |
|---|---|
| Receipt number | R000033075 |
| Scientific Title | Examination of diagnosis and treatment evaluation of leg and foot fatigue fractures by X-ray grating interferometer (Talbot-Lau interferomete) |
| Date of disclosure of the study information | 2017/08/30 |
| Last modified on | 2019/01/07 09:29:37 |
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Basic information
Public title
Examination of diagnosis and treatment evaluation of leg and foot fatigue fractures by X-ray grating interferometer (Talbot-Lau interferomete)
Acronym
Examination of diagnosis and treatment evaluation of leg and foot fatigue fractures by X-ray grating interferometer (Talbot-Lau interferomete)
Scientific Title
Examination of diagnosis and treatment evaluation of leg and foot fatigue fractures by X-ray grating interferometer (Talbot-Lau interferomete)
Scientific Title:Acronym
Examination of diagnosis and treatment evaluation of leg and foot fatigue fractures by X-ray grating interferometer (Talbot-Lau interferomete)
Region
| Japan |
Condition
Condition
Fatigue fractures of leg and foot
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, fatigue fractures of the tibia and metatarsal bones were diagnosed using a Talbot-Lau interferometer, and by comparing the effectiveness of diagnosis with simple X-ray image, MRI image and CT image, To evaluate the effectiveness in the early diagnosis and treatment evaluation of fatigue fractures and the safety of the device
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic rate of lower limb fatigue fracture by Talbot-Lau interferometer
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Imaging by Talbot-Low interferometer
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who are aged 20 or over and under 70 years of age at the time of acquiring consent
2) Case in which fatigue fracture is suspected with localized pain, tenderness in the lower leg, feet due to repeated exercise load
3) Patient who signed consent form
Key exclusion criteria
1) Patients who wish to be pregnant or pregnant
2) Persons who are participating in other clinical studies
3) In addition, the patient who the doctor in charge judged as undesirable as the subject of this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yu Mori |
Organization
Tohoku University Hospital
Division name
Department of Orthopeadic Surgery
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
0227177245
yu-mori@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yu Mori |
Organization
Tohoku University Hospital
Division name
Department of Orthopeadic Surgery
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
0227177245
Homepage URL
yu-mori@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Orthopeadic Surgery, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Tohoku University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 30 | 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 | 08 | Month | 30 | Day |
Last modified on
| 2019 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033075
