UMIN-CTR Clinical Trial

Basic information
Public title	The biomechanical assessment using MR mapping for associations ulnar head morphology with wrist articular cartilage damage
Acronym	The wrist MRI trial
Scientific Title	The biomechanical assessment using MR mapping for associations ulnar head morphology with wrist articular cartilage damage: A non-randomized controlled trial
Scientific Title:Acronym	The wrist MRI trial
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to verify that differences of ulnar head morphology affect the cartilage in the wrist using MR which is no radiation exposure.
Basic objectives2	Others
Basic objectives -Others	Biological evaluation
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Values of cartilages in the wrist provided by an examination of qualitative MR
Key secondary outcomes	number of cases of each group of bone morphology, error of region of interest, intra- and inter-rater reliability, ulnar variance, length from base to top of ulnar head, morphology of lunate, ulnar coverage ratio, ratio for the most long axis of ulnar head

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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	An examination of MR
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	50 years-old >
Gender	Male and Female
Key inclusion criteria	#They have no past medical history of their wrists. #They have no symptom in their wrists. #They can receive examinations of MR at our hospital during a period from an approval day to December, 2023. #Age at the time of the examination is older 20 years and less than 50 years old
Key exclusion criteria	#malignant disease #congenital disease #Bone destruction due to the systemic disease (e.g. rheumatoid arthritis) #metabolic bone disease (e.g. osteoporosis) #The person who cannot receive an examination of MR because of implanted metal in the body, claustrophobia, and the like #The person who cannot understand the purpose and method of this study
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hirotaka Middle name Last name Okubo
Organization	Department of Orthopedic Surgery, Graduate School of Medicine, University of the Ryukyus
Division name	Department of Orthopedic Surgery
Zip code	903-0215
Address	270 Uehara, Nishihara, Okinawa, Japan
TEL	+81988951174
Email	okubo531@u-ryukyu.ac.jp

Public contact
Name of contact person	1st name Keiko Middle name Last name Onaka
Organization	Department of Orthopedic Surgery, Graduate School of Medicine, University of the Ryukyus
Division name	Department of Orthopedic Surgery
Zip code	903-0215
Address	270 Uehara, Nishihara, Okinawa, Japan
TEL	+81988951174
Homepage URL
Email	k208750@eve.u-ryukyu.ac.jp

Sponsor
Institute	Department of Orthopedic Surgery, Graduate School of Medicine, University of the Ryukyus
Institute
Department

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	Ethics committee of university of the Ryukyus for medical and health research involving human subjects
Address	270 Uehara, Nishihara, Okinawa, Japan
Tel	+81988951542
Email	krinken@acs.u-ryukyu.ac.jp

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	2021 Year 12 Month 01 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	2021 Year 11 Month 30 Day
Date of IRB	2021 Year 11 Month 30 Day
Anticipated trial start date	2021 Year 12 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 06 Month 25 Day
Last modified on	2021 Year 08 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050996