UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A survey of the median nerve elasticity after volar locking plate fixation using ultrasound elastography.
Title of the study (Brief title)	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	Kiyohito NAITO
Organization	Juntendo University School of Medicine
Division name	Department of Orthopaedics
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421 Japan.
TEL	03-3813-3111
Email	knaito@juntendo.ac.jp

Public contact
Name of contact person	Kiyohito NAITO
Organization	Juntendo University School of Medicine
Division name	Department of Orthopaedics
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421 Japan.
TEL	03-3813-3111
Homepage URL
Email	knaito@juntendo.ac.jp

Sponsor
Institute	Juntendo University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036302