UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042979 |
|---|---|
| Receipt number | R000049060 |
| Scientific Title | A novel and alternative morphologic radiological parameter to pelvic incidence in assessing spinopelvic sagittal alignment |
| Date of disclosure of the study information | 2021/01/13 |
| Last modified on | 2021/01/12 16:30:47 |
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Basic information
Public title
A novel and alternative morphologic radiological parameter to pelvic incidence in assessing spinopelvic sagittal alignment
Acronym
A novel and alternative morphologic radiological parameter to pelvic incidence in assessing spinopelvic sagittal alignment
Scientific Title
A novel and alternative morphologic radiological parameter to pelvic incidence in assessing spinopelvic sagittal alignment
Scientific Title:Acronym
A novel and alternative morphologic radiological parameter to pelvic incidence in assessing spinopelvic sagittal alignment
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the reliability of our novel morphologic parameters and the correlations with established sagittal spinopelvic parameters.
Basic objectives2
Others
Basic objectives -Others
relationship
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the correlations with established sagittal spinopelvic parameters
Key secondary outcomes
the reliability of our novel morphologic parameters
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
volunteers with no history of treatment for spinal disease
Key exclusion criteria
(1) spinal deformities such as scoliosis, lumbar spondylolisthesis, or transitional vertebrae
(2) hip joint abnormalities, including necrosis of the femoral head, osteoarthritis, and developmental dysplasia of hip
(3) large axial rotation of the pelvis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuhito |
| Middle name | |
| Last name | Takahashi |
Organization
Niigata Rosai Hospital
Division name
Department of Orthopedic Surgery
Zip code
9428502
Address
1-7-12 Touncho, Joetsu City, Niigata
TEL
0255433123
fayas556@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yasuhito |
| Middle name | |
| Last name | Takahashi |
Organization
Niigata Rosai Hospital
Division name
Department of Orthopedic Surgery
Zip code
9428502
Address
1-7-12 Touncho, Joetsu city, Niigata
TEL
0255433123
Homepage URL
fayas556@yahoo.co.jp
Sponsor or person
Institute
Niigata Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
the Clinical Research Ethics Committee of Niigata Rosai Hospital
Address
1-7-12 Touncho, Joetsu City, Niigata
Tel
0255433123
info@niigatah.johas.go.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
| 2021 | Year | 01 | Month | 13 | 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
121
Results
Results date posted
| 2021 | Year | 01 | Month | 12 | Day |
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
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Whole-body alignment in the standing position was measured using a slot-scanning X-ray imager. We measured the established spinopelvic sagittal parameters and a novel parameter: the sacral incidence to pubis (SIP). The correlation coefficient of each parameter, regression equation of pelvic incidence (PI) using SIP, and regression equation of lumbar lordosis using PI or SIP were obtained. The intraclass correlation coefficient was calculated as an evaluation of the measurement reliability.
Management information
Registered date
| 2021 | Year | 01 | Month | 12 | Day |
Last modified on
| 2021 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049060
| 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 |
