UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031801 |
|---|---|
| Receipt number | R000036302 |
| Scientific Title | A survey of the median nerve elasticity after volar locking plate fixation using ultrasound elastography. |
| Date of disclosure of the study information | 2018/03/20 |
| Last modified on | 2018/03/19 18:32:33 |
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Basic information
Public title
A survey of the median nerve elasticity after volar locking plate fixation using ultrasound elastography.
Acronym
ULTRASOUND ELASTOGRAPHY FOR MEDIAN NERVE.
Scientific Title
A survey of the median nerve elasticity after volar locking plate fixation using ultrasound elastography.
Scientific Title:Acronym
ULTRASOUND ELASTOGRAPHY FOR MEDIAN NERVE.
Region
| Japan |
Condition
Condition
Distal radius fractures
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, elasticity of the median nerve was quantified using ultrasound elastography (Real-Time Tissue Elastography (EG)) and compared between the operation and healthy sides in patients after surgery for DRF using VLP.
Basic objectives2
Others
Basic objectives -Others
The influence of the plate type on the median nerve was evaluated by measuring the nerve elasticity.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The subjects who could be examined by EG 6 months or more after surgery.
The elasticity of the MN and the TF was assessed as the AC/MN and AC/TF strain ratio.
Key secondary outcomes
The range of motion of the wrist, grip strength (%ratio to the healthy side), Visual Analog Scale (VAS), Quick Disabilities of the Arm, Shoulder and Hand (Q-DASH) score, and Mayo wrist score were measured in postoperative clinical evaluation
Base
Study type
Observational
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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Distal radius fractures patients
Key exclusion criteria
The subjects who could be examined by EG 6 months or more after surgery
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyohito NAITO |
Organization
Juntendo University School of Medicine
Division name
Department of Orthopaedics
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421 Japan.
TEL
03-3813-3111
knaito@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyohito NAITO |
Organization
Juntendo University School of Medicine
Division name
Department of Orthopaedics
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421 Japan.
TEL
03-3813-3111
Homepage URL
knaito@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University School of Medicine
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 | 03 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special mention
Management information
Registered date
| 2018 | Year | 03 | Month | 19 | Day |
Last modified on
| 2018 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036302
