UMIN-CTR Clinical Trial

Basic information
Public title	Impact of intraoperative measurement technique of coronal spinal alignment using a navigational spinal rod bending system for adult spinal deformity cases
Acronym	Impact of intraoperative measurement technique of coronal spinal alignment using a navigational spinal rod bending system for adult spinal deformity cases
Scientific Title	Impact of intraoperative measurement technique of coronal spinal alignment using a navigational spinal rod bending system for adult spinal deformity cases
Scientific Title:Acronym	Impact of intraoperative measurement technique of coronal spinal alignment using a navigational spinal rod bending system for adult spinal deformity cases
Region	Japan

Condition
Condition	Degenerative lumbar kyphoscoliosis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefulness of the new technique of intraoperative coronal spinal alignment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of postoperative coronal spinal malalignment within one month after long corrective fusion surgery
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Degenerative lumbar kyphoscoliosis with a Cobb angle >20 degrees and lumbar lordosis <20 degrees who underwent corrective surgery of the thoracic to the pelvis in our institute since 2015 have been included in this study.
Key exclusion criteria	Cases who are considered inappropriate for this study.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Masanari Middle name Last name Takami
Organization	Wakayama Medical University
Division name	Orthopaedic surgery
Zip code	6418510
Address	811-1 Kimiidera, Wakayama
TEL	0734410645
Email	takami@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Masanari Middle name Last name Takami
Organization	Wakayama Medical University
Division name	Orthopaedic surgery
Zip code	6418510
Address	811-1 Kimiidera, Wakayama
TEL	0734410645
Homepage URL
Email	takami@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University, department of orthopaedic surgery
Institute
Department

Funding Source
Organization	Wakayama Medical University, department of orthopaedic surgery
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Ethics Committee of Wakayama Medical University
Address	811-1 Kimiidera, Wakayama
Tel	0734410645
Email	wa-rinri@wakayama-med.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	2020 Year 10 Month 17 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	67
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	2020 Year 01 Month 17 Day
Date of IRB	2020 Year 03 Month 11 Day
Anticipated trial start date	2020 Year 03 Month 11 Day
Last follow-up date	2020 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The following demographic characteristics of patients at baseline were investigated: sex, age, body mass index (BMI), and preoperative sagittal and coronal spinal alignment. As sagittal alignment parameters, pelvic incidence (PI), lumbar lordosis (LL), pelvic tilt (PT), sacral slope (SS), PI-LL mismatch, sagittal vertical axis (SVA) were evaluated preoperatively. As coronal alignment parameters, lumbar Cobb angle, C7-CSVL (deviation of C7 plumb line off central sacral vertical line), coronal malalignment pattern (concave CSM and convex CSM) by referring to the report by Obeid et al., L5 tilt angle, S1 tilt angle, sum of coronal deformity angles obtained by adding a coronal wedge-shaped deformity angle of each vertebral body from L1 to L5 to above-mentioned S1 tilt (CDA), and coronal spinal rigidity (CSR) defined as the reduction ratio of Cobb angle between standing and traction position in the frontal view of X-ray were measured. For an evaluation of accuracy of this method, coronal alignment of a fused range by instrumentation was investigated, that is, UIV-CSVL (deviation of upper instrumented vertebra plumb line off central sacral vertical line) obtained finally by this method during surgery was compared with an usual measurement method on the standing position X-ray postoperatively. For an evaluation of efficacy of this method, postoperative C7-CSVL on the standing position X-ray was compared between this method group and conventional method group. Furthermore, incidence of postoperative coronal malalignment was compared in both groups. For the postoperative measurement, a whole spinal X-ray image on the standing position within four weeks after surgery was used.

Management information
Registered date	2020 Year 10 Month 17 Day
Last modified on	2020 Year 10 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048108