UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019151 |
|---|---|
| Receipt number | R000022139 |
| Scientific Title | The study of three dimensional corrective surgery with patient matched surgical instruments. |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2020/04/02 14:28:28 |
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Basic information
Public title
The study of three dimensional corrective surgery with patient matched surgical instruments.
Acronym
The study of three dimensional corrective surgery.
Scientific Title
The study of three dimensional corrective surgery with patient matched surgical instruments.
Scientific Title:Acronym
The study of three dimensional corrective surgery.
Region
| Japan |
Condition
Condition
limb bones and bony skeleton with deformity
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the corrective osteotomy for the bone deformities, conventional preoperative planning with two-dimensional plain radiographs has not always provided sufficient information to understand the complex three-dimensional deformity. Surgeons has estimated the amount of reduction and manually corrected in the actual surgery. We have developed 3D computer simulations and a custom-made surgical guide to perform accurate corrective osteotomy. The custom-made surgical guide was obtained the regulatory approval in the distal humerus and the distal radius. The purpose of this study is to examine the surgical guide applying to limb bones and bony skeleton.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficiency and availability of the surgical guide are evaluated to compare the preoperative simulation and the postoperative results by measuring the deformity with the X ray.
Key secondary outcomes
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
Surgery for deformity correction of limb bones and bony skeleton using custom-made surgical guide based on preoperative computer simulation with CT data
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Deformity of the upper extremity (malunited fracture, early closure of the growth plate, congenital anomaly)
Key exclusion criteria
1. Sever shortening of the bone that cannot be corrected at one time.
2. Inappropriate candidate for general anesthesia.
3. Patient who is pregnant or possibly pregnant. Patient who hope to be pregnant during her trial.
4. Patient who has mental disorder and can not understand the significance of the study and preserve the compliance rules.
5. Patient who is administrated anticoagulant that cannot be interrupted for the operation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kunihiro |
| Middle name | |
| Last name | Oka |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
565-0871
Address
2-2, Yamada-Oka, Suita, Osaka
TEL
06-6879-3552
oka-kunihiro@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kunihiro |
| Middle name | |
| Last name | Oka |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
565-0871
Address
2-2, Yamada-Oka, Suita, Osaka
TEL
06-6879-3552
Homepage URL
oka-kunihiro@umin.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Osaka University Hospital
Address
2-2 Yamadaoka Suita Osaka
Tel
06-6210-8290
rinri@hp-crc.med.osaka-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
| 2015 | Year | 10 | 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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 29 | Day |
Last modified on
| 2020 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022139
