UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030024 |
|---|---|
| Receipt number | R000034285 |
| Scientific Title | Clinical application for treatment of fractures using autologous and/or allogenic bone screws |
| Date of disclosure of the study information | 2017/11/18 |
| Last modified on | 2020/02/10 10:46:30 |
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Basic information
Public title
Clinical application for treatment of fractures using autologous and/or allogenic bone screws
Acronym
Clinical application for treatment of fractures using autologous and/or allogenic bone screws
Scientific Title
Clinical application for treatment of fractures using autologous and/or allogenic bone screws
Scientific Title:Acronym
Clinical application for treatment of fractures using autologous and/or allogenic bone screws
Region
| Japan |
Condition
Condition
Osteochondral fracture, Scaphoid fracture, Factures similar to them
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical outcomes of osteosynthesis using autologous and/or allogenic bone screw, and to evaluate its effectiveness and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective and objective clinical score
Key secondary outcomes
Image assessment (Plain X-ray, CT, MRI)
Arthroscopic assessment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Make bone screw from autologous and/or allogenic bone using a precision processing machine (non-medical equipment).
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
| 10 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who require osteosynthesis because of free osteochondral fragments within the joint due to intra-articular fracture or osteochodritis dissecans.
2. Patients who require osteosynthesis because of scaphoid fracture or similar type of fractures (small bone fractures).
Key exclusion criteria
1. Patients with skin disease or infection around the target site.
2. Patients with malignancy or the history of that.
3. Patients with mental disorder or disturbance of consciousness.
4. Patients with drug allergy.
5. Patients suffering from severe acute illness within 6 months from the day of surgery.
6. Patients with severe kidney/liver disease, heart disease, blood disease, endocrine disease.
7. Patients with extremely low nutritional status. (Alb < 2g/dl)
8. Pregnant women, Patients who may be pregnant, and breast-feeding patients.
9. Other patients who were judged inappropriate as subjects of this research by the research director of research sharing person.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Imade |
Organization
Shimane university, Faculty of medicine
Division name
Department of orthopaedic surgery
Zip code
693-8501
Address
89-1, Enya, Izumo, Shimane, Japan
TEL
0853-20-2242
imades@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Imade |
Organization
Shimane university, Faculty of medicine
Division name
Department of orthopaedic surgery
Zip code
693-8501
Address
89-1, Enya, Izumo, Shimane, Japan
TEL
0853-20-2242
Homepage URL
imades@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane university, Faculty of medicine, Department of orthopaedic surgery
Institute
Department
Personal name
Funding Source
Organization
Shimane university, Faculty of medicine
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
Shimane university institutional committee on ethics
Address
89-1, Enya, Izumo, Shimane, Japan
Tel
0853-20-2515
kenkyu@med.shimane-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
島根大学医学部附属病院（島根県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 18 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2006 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2006 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2007 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 18 | Day |
Last modified on
| 2020 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034285
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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