UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044523 |
|---|---|
| Receipt number | 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 00:16:11 |
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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
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
icalortho@gmail.com
Sponsor or person
Institute
The is no funding sponsor for this research
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
