UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033207 |
|---|---|
| Receipt number | R000037863 |
| Scientific Title | Biological characteristics of femoralintramedullary tissues obtained from patients undergoing autologous bone graft |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2026/01/03 17:57:10 |
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Basic information
Public title
Biological characteristics of femoralintramedullary tissues obtained from patients undergoing autologous bone graft
Acronym
Biological characteristics of femoralintramedullary tissues
Scientific Title
Biological characteristics of femoralintramedullary tissues obtained from patients undergoing autologous bone graft
Scientific Title:Acronym
Biological characteristics of femoralintramedullary tissues
Region
| Japan |
Condition
Condition
fracture, nonunion, bone defect
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine biological characteristics of intramedullary tissues excavated and collected from patients who require autologous bone grafting by RIA system.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigation of biological characteristics of femoral intramedullary tissues
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo autogenous bone grafting from the femur using the RIA system for the treatment of fractures, nonunions, bone defects
(1) The age at the time of consent acquisition is over 20 years.
(2) Document consent has been obtained from the subject person to this research.
Key exclusion criteria
Patients who are judged inappropriate as the subject of this research by the research directors.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Oe |
Organization
kobe University Hospital
Division name
Department of Orthopaedic surgery
Zip code
6500017
Address
7-5-2, Kusunoki-Cho, Chuo-Ku, Kobe City, Hyogo,Japan
TEL
078-382-5985
keiuskeo@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Oe |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Orthopaedic surgery
Zip code
6620025
Address
7-5-2, Kusunoki-Cho, Chuo-Ku, Kobe City, Hyogo,Japan
TEL
078-382-5985
Homepage URL
keisukeo@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe University
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
kobe University Graduate School of Medicine
Address
7-5-2, Kusunoki-Cho, Chuo-Ku, Kobe City, Hyogo,Japan
Tel
078-382-5985
keisukeo@med.kobe-u.ac.jp
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
| 2018 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
no
Publication of results
Unpublished
Result
URL related to results and publications
no
Number of participants that the trial has enrolled
6
Results
Intraoperative samples (tissue excavated from the femoral bone marrow) were collected from the six patients, and adhesion cells were identified and isolated from each sample. These cells were then used to investigate the cytotoxicity of gentamicin. All of the samples showed biological activity, allowing the research to proceed smoothly.
Results date posted
| 2025 | Year | 07 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 03 | Month | 01 | Day |
Baseline Characteristics
Patients were selected to undergo autogenous bone grafting to treat nonunion, and autogenous bone was harvested from the patient's femur using a reaming device.
Participant flow
The study details were explained to patients at the time of surgery, and patients who gave their consent were included in the study.
Adverse events
no
Outcome measures
Cell proliferation
Apoptosis
ALP activity
Gene expression of proteins related to bone generation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 06 | Month | 29 | Day |
Last modified on
| 2026 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037863
