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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015506
Receipt No. 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

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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
Email 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
Email k-sakai@st-mary-med.or.jp

Sponsor
Institute St Mary 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
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018011

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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