UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051812 |
|---|---|
| Receipt number | R000059128 |
| Scientific Title | Imaging analysis, intraoperative evaluation, and postoperative evaluation of exacerbation of scoliosis |
| Date of disclosure of the study information | 2023/08/10 |
| Last modified on | 2023/08/03 11:49:27 |
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Basic information
Public title
Imaging analysis, intraoperative evaluation, and postoperative evaluation of exacerbation of scoliosis
Acronym
Imaging analysis, intraoperative evaluation, and postoperative evaluation of exacerbation of scoliosis
Scientific Title
Imaging analysis, intraoperative evaluation, and postoperative evaluation of exacerbation of scoliosis
Scientific Title:Acronym
Imaging analysis, intraoperative evaluation, and postoperative evaluation of exacerbation of scoliosis
Region
| Japan |
Condition
Condition
scoliosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyze the causes of deterioration of scoliosis using imaging and bone metabolism tests, and if surgical treatment is necessary, perform an imaging evaluation of the effectiveness of intervertebral dissection during surgery. Final evaluation of postoperative outcome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient standing type QOL evaluation (ODQ, RDQ), Japanese scoliosis society evaluation sheet (SRS-22), spine simple CT, intraoperative cone-beam CT (before screw insertion, before and after correction), intraoperative dissection using Ponte device Evaluation of operation, evaluation of spinal cord blood flow, evaluation of spinal cord function monitoring, examination of bone metabolic dynamics (NTx, PTH, TRAP-5b), bone density, pre- and postoperative whole spine plain radiographs (standing front and lateral)
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have scoliosis, are planning to undergo brace treatment or surgical treatment, and have given consent to participate in the study
Key exclusion criteria
1. Preschool children under the age of 6
2. Patients who have difficulty filling out questionnaires or understanding tests due to dementia or intellectual disability
3. In the case of minors, patients without parental consent
An orthopedic specialist determines the disease
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shoji |
| Middle name | |
| Last name | Seki |
Organization
Toyama Univ
Division name
orthopedics
Zip code
9300152
Address
Toyama-ken Toyama-shi Sugitani 2630
TEL
0764347353
seki@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Shoji |
| Middle name | |
| Last name | Seki |
Organization
Toyama Univ
Division name
orthopedics
Zip code
9300152
Address
Toyama-ken Toyama-shi Sugitani 2630
TEL
0764347353
Homepage URL
seki@med.u-toyama.ac.jp
Sponsor or person
Institute
Toyama Univ
Institute
Department
Personal name
Funding Source
Organization
Toyama Univ
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
University of Toyama Ethics Review Committee
Address
Toyama-ken Toyama-shi Sugitani 2630
Tel
076-415-8857
rinri@adm.u-toyama.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
| 2023 | Year | 08 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Injury name, medical questionnaire used in normal medical care, blood collection results, bone density, simple X-ray, CT, MRI image data, dissection data measured during surgery, ultrasound data, spinal cord monitoring data.
Patient standing type QOL evaluation (ODQ, RDQ), Japanese scoliosis society evaluation sheet (SRS-22), spine simple CT, intraoperative cone-beam CT (before screw insertion, before and after correction), intraoperative dissection using Ponte device Evaluation of operation, evaluation of spinal cord blood flow, evaluation of spinal cord function monitoring, examination of bone metabolic dynamics (NTx, PTH, TRAP-5b), bone density, pre- and postoperative whole spine plain radiographs (standing front and lateral)
Management information
Registered date
| 2023 | Year | 08 | Month | 03 | Day |
Last modified on
| 2023 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059128
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
