UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of superior plating and anteroinferior plating for midshaft clavicle fractures.
Acronym	Comparison of superior plating and anteroinferior plating for midshaft clavicle fractures.
Scientific Title	Comparison of superior plating and anteroinferior plating for midshaft clavicle fractures.
Scientific Title:Acronym	Comparison of superior plating and anteroinferior plating for midshaft clavicle fractures.
Region	Japan

Condition
Condition	midshaft clavicle fractures
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to compare the clinical results using superior plating and anteroinferior plating for midshaft clavicle fractures.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Implant-related irritation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Superior plating for midshaft clavicle fractures
Interventions/Control_2	Anteroinferior plating for midshaft clavicle fractures
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. The patients who were diagnosed with midshaft clavicle fracture 2. The patients who visited to our hospital 18 years or older 3. The patients who had displaced midshaft clavicle fracture which is no cortical contact between the medial and distal fragment and/or >2cm shortening on Xp and CT 4. Surgery within 3 Weeks after trauma 5. The patients who obtained the consent in this study 6. The patients of minor who can be obtained informed consent by their guardians
Key exclusion criteria	1. The patients who had symptomatic nonunion after conservative treatment of midshaft clavicle fractures 2. The patients who had midshaft clavicle fracture again 3. The patients who had a surgical history, pain, dysfunction of the shoulder before trauma. 4. The patients who had an associated scapular or humeral fracture 5. Open fracture 6. The proximal or distal one third fracture of the clavicle 7. Pathological fracture 8. The patients who had an associated neurovascular injury 9. The patients who was not obtained the consent in this study.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tomohiko Middle name Last name Minamikawa
Organization	Fukuoka University Chikushi Hospital
Division name	Dept. of Orthop. Surg.
Zip code	818-8502
Address	1-1-1, Zokumyoin, Chikushino, Fukuoka
TEL	092-921-1011
Email	tomominamikawa@yahoo.co.jp

Public contact
Name of contact person	1st name Tomohiko Middle name Last name Minamikawa
Organization	Fukuoka University Chikushi Hospital
Division name	Dept. of Orthop. Surg.
Zip code	818-8502
Address	1-1-1, Zokumyoin, Chikushino, Fukuoka
TEL	092-921-1011
Homepage URL
Email	tomominamikawa@yahoo.co.jp

Sponsor
Institute	Fukuoka University Chikushi Hospital
Institute
Department

Funding Source
Organization	None
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	Fukuoka University Chikushi Hospital
Address	1-1-1, Zokumyoin, Chikushino, Fukuoka
Tel	092-921-1011
Email	chikushirinsho@adm.fukuoka-u.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	2019 Year 05 Month 06 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	Open public recruiting
Date of protocol fixation	2019 Year 04 Month 28 Day
Date of IRB	2019 Year 05 Month 13 Day
Anticipated trial start date	2019 Year 08 Month 06 Day
Last follow-up date	2023 Year 03 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	2019 Year 04 Month 29 Day
Last modified on	2019 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041724