UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015506 |
|---|---|
| Receipt number | R000018011 |
| Scientific Title | Primary Hinged External Fixation of Complex Fracture Dislocations of the Elbow ; A New Strategy for Terrible Triad Injury and Olecranon Fracture Dislocation |
| Date of disclosure of the study information | 2014/10/22 |
| Last modified on | 2014/10/22 20:38:15 |
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Basic information
Public title
Primary Hinged External Fixation of Complex Fracture Dislocations of the Elbow ; A New Strategy for Terrible Triad Injury and Olecranon Fracture Dislocation
Acronym
Primary Hinged External Fixation of Complex Fracture-Dislocations of the Elbow
Scientific Title
Primary Hinged External Fixation of Complex Fracture Dislocations of the Elbow ; A New Strategy for Terrible Triad Injury and Olecranon Fracture Dislocation
Scientific Title:Acronym
Primary Hinged External Fixation of Complex Fracture-Dislocations of the Elbow
Region
| Japan |
Condition
Condition
fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our hypothesis is that lateral collateral ligament (LCL) injuries without gross instability, fractures of the coronoid process, and CBCC injuries may be repaired without an operation or with a minimally invasive technique if a hinged external fixator is used to protect the internal fixation and maintain concentric reduction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The patients were evaluated on the basis of clinical findings, with the Mayo elbow performance score [19] used for clinical assessment. Radiographs were reviewed at the last follow-up visit.
Key secondary outcomes
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
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Primary Hinged External Fixation
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
| 23 | years-old | <= |
Age-upper limit
| 82 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
complex fracture-dislocations of the elbow
Key exclusion criteria
simple dislocations of the elbow
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kensuke Sakai, M.D |
Organization
St Mary's Hospital
Division name
Orthopaedics
Zip code
Address
422 Tsubukuhon-machi, Kurume City, Fukuoka 830-0543, Japan
TEL
+81-942-35-3322
k-sakai@st-mary-med.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensuke Sakai, M.D |
Organization
St Mary Hospital
Division name
Orthopaedics
Zip code
Address
422 Tsubukuhon-machi, Kurume City, Fukuoka 830-0543, Japan
TEL
+81-942-35-3322
Homepage URL
k-sakai@st-mary-med.or.jp
Sponsor or person
Institute
St Mary 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
Address
Tel
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
| 2014 | Year | 10 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2010 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 22 | Day |
Last modified on
| 2014 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018011
| 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 |
