UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036624 |
|---|---|
| Receipt number | 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 20:46:24 |
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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
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
tomominamikawa@yahoo.co.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041724
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
