UMIN-CTR Clinical Trial

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