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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036624
Receipt No. R000041724
Scientific Title Comparison of superior plating and anteroinferior plating for midshaft clavicle fractures.
Date of disclosure of the study information 2019/05/06
Last modified on 2019/11/07

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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/ctr_e/ctr_view.cgi?recptno=R000041724

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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