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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044523
Receipt No. R000050872
Scientific Title Ilizarov method for bone and soft tissue defect
Date of disclosure of the study information 2021/06/14
Last modified on 2021/06/14

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Basic information
Public title The efficacy of ilizarov method for management of long tibial bone and soft tissue defect
Acronym TEOIMFMOLTBASTD
Scientific Title Ilizarov method for bone and soft tissue defect
Scientific Title:Acronym IMFBASTD
Region
Asia(except Japan)

Condition
Condition Patients with open fracture Gustillo-Anderson type III had undergone several surgical procedures, but still ended up with expose long dead bone or infected
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 used to address long bone and soft tissue defect after re-debridement with radical resection of long dead bone or infected segment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes soft tissue closure without tertiary soft tissue procedure
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
19 years-old <=
Age-upper limit
33 years-old >=
Gender Male and Female
Key inclusion criteria non-union tibial fracture with exposed long-dead bone or infected bone segment, that had been confirmed clinically and by x-ray
Key exclusion criteria non-trauma cases (e.g. pathological fracture), any additional pathology and loss of follow up
Target sample size 14

Research contact person
Name of lead principal investigator
1st name Faisal
Middle name
Last name Miraj
Organization Fatmawati General Hospital, Jakarta, Indonesia
Division name Pediatrics Orthopaedics and Limb Reconstruction Division, Department of Orthopaedics and Traumatology
Zip code 12430
Address RS. Fatmawati Raya Street Number 4, RT.4/RW.9, Cilandak Bar., Cilandak, Kota Jakarta Selatan, Daerah Khusus Ibukota Jakarta
TEL +62217501524
Email icalortho@gmail.com

Public contact
Name of contact person
1st name Faisal
Middle name
Last name Miraj
Organization Fatmawati General Hospital, Jakarta, Indonesia
Division name Pediatrics Orthopaedics and Limb Reconstruction Division, Department of Orthopaedics and Traumatolog
Zip code 12430
Address RS. Fatmawati Raya Street Number 4, RT.4/RW.9, Cilandak Bar., Cilandak, Kota Jakarta Selatan
TEL +62217501524
Homepage URL
Email icalortho@gmail.com

Sponsor
Institute The is no funding sponsor for this research
Institute
Department

Funding Source
Organization The is no funding source for this research
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia
Address Jl. Salemba Raya No.6, RW.5, Kenari, Kec. Senen, Kota Jakarta Pusat, Daerah Khusus Ibukota Jakarta
Tel +62211500135
Email ec_fkui@yahoo.com

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
2021 Year 06 Month 14 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 14
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 No longer recruiting
Date of protocol fixation
2020 Year 01 Month 01 Day
Date of IRB
2021 Year 05 Month 30 Day
Anticipated trial start date
2020 Year 01 Month 05 Day
Last follow-up date
2020 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information An observation about the pain, leg length evaluation, and defect closure

Management information
Registered date
2021 Year 06 Month 14 Day
Last modified on
2021 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050872

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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