UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004618 |
|---|---|
| Receipt number | R000005513 |
| Scientific Title | Development of custom-made surgical guide for osteotomy and screw insertion. |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2012/05/27 01:27:58 |
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Basic information
Public title
Development of custom-made surgical guide for osteotomy and screw insertion.
Acronym
Custom-made surgical guide for osteotomy and screw insertion.
Scientific Title
Development of custom-made surgical guide for osteotomy and screw insertion.
Scientific Title:Acronym
Custom-made surgical guide for osteotomy and screw insertion.
Region
| Japan |
Condition
Condition
Orthopedic patients to be undergone surgery with osteotomy or screw insertion.
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a custom-made surgical guide for orthopedic surgery which make osteotomy and screw insertion more easy and safely.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
To avoid major vascular and neurological injury in association with osteotomy and screw insertion.
Key secondary outcomes
Intra- and postoperative evaluation of efficacy and problem of the surgical guide.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Groups using surgical guide.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Orthopedic patient to be undergone surgery with osteotomy or screw insertion.
2)Patient with written consent to participate this trial.
Key exclusion criteria
1) Patient without computed tomography image with adequate resolution for the guide preparation.
2) Patient without enough time for the guide preparation.
3) Patient who considered as inadequate for participate this trial by the medical attendant responsible for this trial.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuru Takemoto |
Organization
Department of Orthopaedic surgery, Kyoto University Hospital.
Division name
Orthopaedic surgery
Zip code
Address
Sakyo-ku, Shogo-in, Kawahara-cho 54
TEL
075-751-3362
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuru Takemoto |
Organization
Kyoto University
Division name
Department of Orthopaedic Surgery
Zip code
Address
TEL
Homepage URL
m.take@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-aid from the Ministry of Health, Labour, and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
京都大学病院（京都府）
滋賀小児保健医療センター（滋賀県）
大阪赤十字病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 01 | 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
| 2010 | Year | 11 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 25 | Day |
Last modified on
| 2012 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005513
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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