Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06085651 |
| Other study ID # |
NFEC-2023-225 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2023 |
| Est. completion date |
June 1, 2024 |
Study information
| Verified date |
October 2023 |
| Source |
Nanfang Hospital, Southern Medical University |
| Contact |
Fu tao Li, M.D |
| Phone |
86-20-6278 7195 |
| Email |
1012095069[@]qq.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Adolescent idiopathic scoliosis (AIS) is the most common three-dimensional deformity of the
spine that is typically characterized by curvature in both the coronal and sagittal planes.
Selective thoracolumbar fusion (STLF) surgery, is an established corrective surgical
technique for spinal deformities with excellent outcomes over time1. The objective of AIS
corrective surgery encompasses the rectification of coronal and spinal rotation deformities
while concurrently restoring the sagittal profile. However, some scholars suggested that
correcting the Cobb angle and rotation deformity of the main thoracic curve has been
associated with a sacrifice of sagittal plane aligament. Some researchers observed that
significant reduction of thoracic kyphosis (TK) after the coronal deformity was corrected in
their study3-5. In addition, Li et al3 found that both lumbar lordosis(LL) and sacral slope
(SS) decreased after STLF surgery in their study. The sagittal plane of the spine column
should be considered a chain-like structure, one section's change, that leads to compensatory
changes in other segments, enables the maintenance of balance6. In addition, some scoloars
suggested that the decrease in thoracic kyphosis may caused by vertebral derotation in STLF
surgery.
Postoperative shoulder imbalance (PSI) is a common complication that arises following STLF
surgery, significantly impacting the appearance and satisfaction of patients8. The incidence
of PSI varies within a range of 25% to 57%. It is imperative to identify the independent risk
factors of PSI which can help in comprehending this phenomenon better and further aiding in
deduction of the incidence rate. Although the research on the risk factors for PSI in AIS
patients have been conducted for several years , no conclusively determination has been
reached. Recently, scholars have been studying the relationship between the rotation of the
thoracic spinal column and postoperative shoulder balance. Yagi et al.'s study10 has
identified the preoperative rotation of the main thoracic apical vertebrae as a risk factor
for PSI. Additionally, Masayoshi et al has reported on the relationship between the rotation
of the proximal thoracic apical vertebrae and postoperative shoulder height disatance.
In summary, it can be hypothesized that the preoperative and changes of postoperative
sagittal spinal parameters may impact the postoperative shoulder balance among AIS patients.
However, there is a paucity of literature investigating the effect of sagittal spinal
parameters on PSI after STLF surgery. Therefore, the purpose of this study is to examine the
correlation between the preoperative and postoperative alterations of sagittal spinal
parameters and PSI.
Description:
PSI as a postoperative complication of Selective Thoracic-Lumbar Fusion (STLF) in AIS
patients has been proven by numerous scholars to be an important factor affecting patients'
satisfaction with the surgery and the mental health of adolescents, with an incidence rate of
25%-57%. Currently, most scholars' research on shoulder imbalance risk factors is mainly
focused on coronal plane parameters and still remains highly controversial.In their study,
Lee found that the preoperative Risser sign level of the PSI group was significantly higher
than that of the non-PSI group during postoperative follow-up. Some domestic experts believe
that the preoperative upper thoracic Cobb angle (PTC Cobb) and the ratio of preoperative
upper thoracic to main thoracic curves (Pre PTC/MTC) have a certain predictive value for the
occurrence of PSI after surgery. It has also been shown that the preoperative shoulder
imbalance in the PSI group was significantly more severe than in the non-PSI group during the
last follow-up. The preoperative presence of shoulder imbalance is of great significance in
guiding the surgeon's choice of upper instrumented vertebra (UIV). Rose, Lenke, Qiu Yong, and
others believe that different preoperative shoulder heights should lead to different choices
of UIV. When the right shoulder is higher, it is recommended to fix the UIV at T4/T5, and
when the preoperative shoulder height is already balanced, the UIV should be selected at T3
or T4. However, when the left shoulder is higher preoperatively, it should be fixed at the T2
level. Brooks, through a study of 648 AIS patients, found that the probability of PSI
occurring after surgery in patients with UIV=T4 is the lowest compared to UIV=T2, T3, T5.
Furthermore, incorrect correction of PTC and MTC by the surgeon can also lead to PSI in
patients. Different researchers have given different answers on how to choose the appropriate
PTC/MTC correction rate. Zhang and others believe that to prevent PSI in Lenke 1 patients
after surgery, it is important to fully correct the upper thoracic curve and appropriately
correct the main thoracic curve. In a study by John et al. on the risk factors for
postoperative PSI in Lenke 1 and 2 patients, it was found that when the correction rate of
the main thoracic curve was greater than 54% and the correction rate of the upper thoracic
curve was less than 52%, 59% of the patients experienced PSI during the last follow-up. In a
study by Ke et al., it was found that when the correction rate of the upper thoracic curve
exceeded 55.3%, 88.4% of the individuals could maintain shoulder balance during the last
follow-up, while when the correction rate of the main thoracic curve was greater than 56% and
the correction rate of the upper thoracic curve was less than 55.3%, 66.3% of AIS patients
would develop PSI at the last follow-up after surgery. Some experts believe that not only the
position of the upper fixed vertebra affects the postoperative shoulder balance but also the
choice of the lowest fixed vertebra affects the postoperative shoulder balance in AIS
patients. To avoid the occurrence of PSI in AIS patients after surgery, Tatsuya Sate suggests
that the lowest fixed vertebra should be selected at the lowest touchable vertebra (LTV) or
the vertebra above LTV.
Although STLF can effectively improve the spinal deformity of AIS patients and has been used
in clinical practice for many years, some scholars have found that while correcting the
coronal imbalance of patients with this procedure, it often sacrifices the sagittal balance.
The size of coronal and sagittal parameters in patients with spinal scoliosis can effectively
assess the severity of spinal deformity. AIS, as a three-dimensional spinal deformity, has a
correlation between sagittal and coronal deformities. Wu et al.'s study indicated that the
main curve Cobb angle in AIS patients is related to sagittal parameters such as thoracic
kyphosis (TK), lumbar lordosis (LL), and sacral slope (SS). Studies have shown that with the
correction of the main curve, it may simultaneously lead to a decrease in sacral slope (SS)
and an increase or decrease in thoracic kyphosis (TK). The sagittal structure of the spine is
considered a chain-like structure, and when there is a change in any segment of the cervical,
thoracic, lumbar spine, and pelvic segments, the remaining segments compensate to restore the
sagittal alignment of the spine. Through the study of the shoulder joint and surrounding
anatomy, it is known that the shoulder joint, spine, and clavicle are not directly connected
but rely on soft tissues such as muscles and ligaments in between, and the support of the
shoulder strap mainly relies on the rhomboid and trapezius muscles. The presence of the
trapezius muscle allows the scapula to adhere closely to the chest wall, avoiding excessive
elevation. When the strength of these muscles changes, the body may not be able to maintain
shoulder balance. In recent years, it has been found that sagittal parameters of the spine,
such as thoracic kyphosis and pelvic incidence angle, are related to the strength of the back
muscles, such as the trapezius and rhomboid muscles. In addition, the magnitude of thoracic
kyphosis (TK) may affect the rotation of the upper curve. Since the rotation axis of the
spine is in front of the thoracic spine, when the thoracic kyphosis decreases, the distance
between the thoracic vertebra and the spinal rotation axis is reduced, resulting in a simpler
rotation of the thoracic vertebra in this segment. The final result may lead to an increase
in the rotation degree of the upper curve. In recent years, Mitsuru Yagi proposed a new
radiographic parameter, the Clavicle-Chest Cage Angle Difference (CCAD). Mitsuru Yagi found
that the CCAD in patients with postoperative PSI group was significantly greater than that in
the non-PSI group during preoperative, postoperative, and postoperative follow-up. Subsequent
studies by Xiao et al. indicated that the preoperative CCAD can effectively predict whether
AIS patients will develop PSI after surgery. Currently, the reasons for the occurrence of
CCAD and how it affects postoperative shoulder balance in AIS remain inconclusive. Some
scholars have proposed several possible reasons for CCAD leading to postoperative PSI in AIS
patients: 1. The existence of residual CCAD after surgery may mean that there is residual
rotational deformity in the upper curve of AIS patients after surgery. The residual
rotational deformity of the upper curve may cause the elevation of the left shoulder,
affecting the postoperative shoulder balance of the patients. 2. The residual rotation of the
upper curve after surgery may lead to atrophy of the soft tissues connecting the shoulder
joint, spine, causing atrophy of the shoulder joint, and eventually resulting in shoulder
imbalance. The relationship between sagittal parameters of the spine and the strength of the
soft tissues connecting the scapula, clavicle, and spine has been reported in previous
studies. In conclusion, we hypothesize that the occurrence of postoperative PSI in AIS
patients may be correlated with the preoperative and postoperative sagittal parameters of the
patients Subject population
The subjects of this study sought medical treatment in the Department of Spinal Orthopedics,
Southern Hospital, Southern Medical University, and referred to the "Clinical Practice
Diagnosis of adolescent idiopathic scoliosis using textbooks such as Orthopedics and Surgery,
as well as imaging evidence
Adolescent idiopathic spine with protruding patients who require posterior selective
thoracolumbar fusion surgery as determined by clinical physicians
Patients with scoliosis.
Diagnostic criteria:
The subjects of this study sought medical treatment in the Department of Spinal Orthopedics,
Southern Hospital, Southern Medical University, and referred to the "Clinical Practice
Diagnosis of adolescent idiopathic scoliosis using textbooks such as Orthopedics and Surgery,
as well as imaging evidence
Adolescent idiopathic spine with protruding patients who require posterior selective
thoracolumbar fusion surgery as determined by clinical physicians
Patients with scoliosis.
Selection criteria:
1. Diagnosed as AIS upon admission;
2. The surgical age is 10-25 years old;
3. The surgical method is posterior selective thoracolumbar fusion;
The last reexamination was between January 2008 and May 2022;
5: AIS patients who need to collect complete imaging data before and after surgery;
5.3 Exclusion criteria:
Previous history of spinal trauma or spinal surgery;
6. Research methods and steps
This is a retrospective case-control study, with plans to collect the last follow-up in
January 2008
AIS patients undergoing posterior selective thoracolumbar fusion surgery at the Spinal
Orthopedics Department of Southern Hospital between May 2022
Preoperative and postoperative imaging data, and all collected imaging data will be used
using IBM SPSS
25.0 (or higher) for statistical analysis without the need for additional visits, laboratory
analysis, or routine analysis
Evaluation beyond clinical practice requirements. Doctors will determine treatment plans
based on diagnostic and treatment standards. Researchers will investigate
Review the patient's medical history and laboratory reports to determine their eligibility
based on inclusion and exclusion criteria. This research application
Exemption from being informed, as the samples and information involved in the study are
sourced from clinical diagnosis and treatment records and specimens
The risk of the patient does not exceed the minimum risk, and exemption from knowing will not
have adverse effects on the patient's rights or health
And if informed research is obtained, it will not be possible to conduct, and the privacy and
personal identity information of the subjects will be protected.
Informed consent and enrollment
This study applies for exemption from informed consent forms, and subjects who meet all other
inclusion/exclusion criteria are considered
For inclusion in this study.
Subject identification number
Each patient and clinical tissue sample is given a unique identification number based on the
imaging findings at the last follow-up examination
Is the difference in shoulder height (RSH) greater than 20mm? Divide patients into PSI group
(RSH ≥ 20mm) and Non PSI group
(RSH < 20mm). If the patient is in the Non PSI group and the enrollment order is 1, the
identification number Non 01 will be given.
All research documents will use this identification number. This identification number does
not contain any combination information that can identify the subject's identity.
Data source/data collection process
By collecting preoperative, postoperative, and follow-up imaging data from patients with AIS,
this study aims to
data Case data, detailed data of relevant imaging parameters, and identification numbers are
uniformly recorded by the researchers in the experiment
In the record table.
Data collection steps
Record demographic data: age, gender;
Collect preoperative and postoperative imaging parameters of patients included in this study;
7. Study Termination/Suspension Criteria
The applicant has the right to terminate/suspend this study. Applicants must be notified
before terminating/suspending a clinical study
Researchers, ethics committees, and relevant regulatory authorities, and provide reasons.
After early termination/suspension of the study, re
New research must be reviewed and approved by the ethics committee;
Termination/suspension requested by the Ethics Committee.
Provisions for ending clinical research.
All preoperative and postoperative imaging data of included patients have been collected.
data management
1 Data Management
1. Researchers must ensure that the data is true, complete, and accurate;
2. When making any corrections to the research records, only underline and annotate the
revised data, explain the reasons, and have the research
Please sign and indicate the date, and do not erase or overwrite the original record;
3. The laboratory inspection items are complete.
Data recording and file storage
The relevant subject data on the case report form should be recorded in the subject coding
format, and subjects can only use the
Identification of the subject's code or initials.
This study uses Microsoft Office for data management, and the verification from data entry to
source data requires
Seek answers to questions about quality control data, and finally, after confirming the
operation of data locking and exporting, and confirming that there are no doubts about the
data,
All parties sign the database locking application form, and the data administrator will lock
the database. After the database is locked,
Export the analysis database by the data administrator and submit it to the statisticians for
statistical analysis. Locked data is not available
After further editing and database locking, any issues found can be corrected in the
statistical analysis program after confirmation.
statistical analysis
Sample size determination
This study is a retrospective case study aimed at exploring the risk factors for shoulder
imbalance in AIS patients after surgery
In a controlled study, the total sample size for current research on disease risk factors is
5-10% of the required number of factors to be explored
Therefore, this study plans to include 100 patients who meet the inclusion and exclusion
criteria.
statistical method
The analysis content includes case distribution, demographic data, and relevant imaging data
that needs to be collected for this study.
Statistical software and general requirements: All statistical analysis shall be completed
using IBM SPSS 25.0 (or higher version).
Measurement data is described using mean, standard deviation, median, maximum, and minimum
values
Count data using frequency and percentage descriptions
Research management
Comply with relevant regulatory requirements
1. Researchers should use standard operating procedures to conduct quality control and
quality assurance systems for clinical studies;
2. The original data must comply with relevant regulatory requirements;
3. The laboratory inspection results must be accurate and reliable;
4. All observations and findings used should be verified to ensure the reliability of the
data;
5. Establish a complete research organization and clarify the responsibilities of personnel
at all levels;
6. The main researchers are responsible for comprehensive quality control and carry out the
responsibilities of personnel at all levels;
7. The main researcher is responsible for designing the research protocol and informed
consent form. After the study is completed, the main researcher
Write a research summary report;
8. The designated researcher is responsible for developing research implementation rules
and SOPs for use in the study;
9. Before the study, the research group organizes a learning plan for all participants, and
all participants must go through the
GCP training;
10. Physicians and nurses participating in the study must strictly abide by the protocol
regulations, follow the procedures, and are not allowed to change at will
Change;
11. The designated statistician is responsible for the comprehensive statistical processing
of the data.
Protecting the privacy of subjects
All data of the subjects during the study period will be entered into a computer for
confidential storage and analysis, if necessary
The shutdown organization may review the records to verify the authenticity, accuracy, and
completeness of the data, and study the obtained information
It may also be published in academic journals, but the names of the participants will not be
disclosed and their privacy will be kept confidential.
Take additional preventive measures to ensure the confidentiality of documents and prevent
the identification of subjects based on genetic data
Identity. However, in special circumstances, some individuals may see the genetic data and
individuals of a certain subject
Identification code. For example, in the event of medical emergency, the sponsor, their
representative doctor, or researcher is aware that
Subject identification code and access to the subject's genetic data. In addition, relevant
regulatory agencies require
Access relevant files.
The problems that occurred during the research and their handling measures 1) Revision of the
plan: After approval by the Ethics Committee, if this plan needs to be revised, a "Plan
Revision
Order instructions "and signed by the main researcher;
2) After the plan is revised, it must be submitted to the Ethics Committee for review and
approval before implementation;
3) No participant in the study shall violate the protocol.
Quality Control and Quality Assurance
Quality assurance:
A cooperation agreement between the applicant and the person entrusted by the applicant to be
responsible for all or part of the responsibilities and tasks related to this study
Each department (including CRO, SMO, statistical unit, clinical center, etc.) should
establish their own quality assurance bodies
Department, fulfill their respective responsibilities, strictly follow the clinical research
protocol, and adopt corresponding standard operating procedures,
To ensure the implementation of clinical research quality control and quality assurance
system.
Quality assurance of clinical research process
Before initiation, researchers should receive training on the research protocol to enable
them to understand the clinical research protocol and its
There is a thorough understanding and understanding of the specific connotations of each
indicator. Quality control personnel should verify the basic conditions of clinical research,
Ensure that the clinical research conditions meet the protocol requirements. During the
research process, researchers should follow the institutional SOP and research
The plan requires careful execution of clinical procedures and other work, and truthful,
timely, complete, and standardized recording.
Quality control personnel conduct quality checks on the research process and corresponding
original records. After the study is completed, the study form
Organize the corresponding project documents, verify them by quality control personnel, and
archive and save them. Quality Assurance of Clinical Research Units
The department conducts feasibility checks on the research conducted. Notify researchers
promptly when non conformities are found
Make corrections with the unit leader and track the progress of the corrections.
