UMIN-CTR Clinical Trial

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
Email	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
Email	fayas556@yahoo.co.jp

Sponsor
Institute	Niigata Rosai Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049060