UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062469 |
|---|---|
| Receipt number | R000069963 |
| Scientific Title | Explore of the factors contributing to coronal decompensation after selective thoracic spinal fusion for Lenke type 1B, 1C, 2B, and 2C curves. |
| Date of disclosure of the study information | 2026/08/07 |
| Last modified on | 2026/08/04 18:09:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Optimal Selection of the Lowest Instrumented Vertebra in Lenke type 1B, 1C, 2B, and 2C curves Adolescent Idiopathic Scoliosis: A Prospective Multicenter Study Based on the Relative Position of the Stable and End Vertebrae
Acronym
Explore of the factors contributing to Coronal decompensation
Scientific Title
Explore of the factors contributing to coronal decompensation after selective thoracic spinal fusion for Lenke type 1B, 1C, 2B, and 2C curves.
Scientific Title:Acronym
Explore of the factors contributing to Coronal decompensation
Region
| Japan | Asia(except Japan) | Australia |
Condition
Condition
idiopathic scoliosis with thoracic structural curves
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Scoliosis is defined as a curvature of 10 degrees or more, measured using the Cobb angle. Cases with a Cobb angle of 40 degrees or more are known to affect the appearance of the trunk (shoulder balance, waistline asymmetry, and a thoracic or lumbar hump) and tend to gradually worsen due to the effects of gravity.
Surgical treatment for scoliosis reduces the Cobb angle, preventing future deterioration and correcting trunk deformities.
Scoliosis is classified into curve types based on the vertebral level where the largest Cobb angle is located. The Lenke classification is particularly frequently used; cases with one major (structural) curve in the thoracic spine are called Lenke type 1, while cases with two major (structural) curves in the thoracic spine are called Lenke type 2. In both Lenke type 1 and 2, depending on the size of the lumbar curve, coronal decompensation of the trunk may remain after surgery, affecting patient satisfaction with the procedure. However, at present, there is insufficient evidence to determine the optimal fixation range for achieving a good postoperative well balance based on the type of lumbar curve in both Lenke type 1 and 2.
This study aims to clarify the factors contributing to coronal decompensation after corrective fixation in Lenke type 1 and 2, and to identify the corrective fixation range that is less likely to cause coronal decompensation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study focuses on the distal vertebral level in cases of selective thoracic spinal fusion. It divides patients into two groups: those who selected a stable vertebra (a vertebra divided in the midline by a perpendicular line from the pelvic center) as the distal fusion end, and those who did not. The study aims to identify cases of postoperative coronal decompensation (lateral shift of the C7 vertebral body greater than 2 cm in the coronal plane) and investigate the influence of distal fusion end selection.
Key secondary outcomes
We compare two groups of patients: one with a stable vertebral end fixation and another with a non-stable vertebral end fixation. The objectives were: 1) to clarify the spontaneous correction of the lumbar curve after surgery, and 2) to clarify the incidence of shoulder imbalance after surgery.
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
| 10 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
structural thoracic curve cases
at least two years follow-up
Lenke classification type 1 B,C and type 2 B,C
Key exclusion criteria
more than equal 31 years olds
patients who do not want to join this study
Lumbar structural curve cases
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Shigematsu |
Organization
Nara medical University
Division name
Orthopaedic surgery
Zip code
6348522
Address
840 Shijocho Kashiharacity, Nara
TEL
0744-22-3051
shideki714@gmail.com
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Shigematsu |
Organization
Nara Medical University
Division name
orthopaedic surgery
Zip code
6348522
Address
840 Shijocho Kashihara city Nara
TEL
0744-22-3051
Homepage URL
shideki714@gmail.com
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Hideki Shigematsu
Funding Source
Organization
Self-funding
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
Nara Medical University
Address
840 Shijocho Kashihara city Nara
Tel
0744223051
ino_rinri@naramed-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
奈良県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 07 | 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
| 2026 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2028 | Year | 12 | Month | 31 | Day |
Other
Other related information
This is a retrospective study and it is not a prospective study involving the enrollment of cases and continuous monitoring of their clinical course. It does not constitute an interventional study. Data will be collected from patient medical records and radiographs.
The study will utilize baseline data which include age, sex, height, weight, skeletal maturity assessment, and measurements derived from whole spine standing radiographs.
The primary outcome is coronal plane imbalance at two years postoperatively.
Secondary outcomes to be investigated include changes in shoulder balance and the spontaneous correction of the lumbar curve.
Management information
Registered date
| 2026 | Year | 08 | Month | 04 | Day |
Last modified on
| 2026 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069963
