The Relaionship Between Sagittal Spinal Parameters and PSI

NCT06085651 | Unknown

• 1 other identifier: NFEC-2023-225
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Adolescent idiopathic scoliosis; postoperative shoulder imbalance

Outcome Measures

Primary Outcomes (1)

• RSH

  RSH was measured as the linear distance between the horizontal reference lines, passing through the soft tissue shadow of the shoulder directly above the acromial clavicular joint of each shoulder.

  baseline, immediately after, and at least 2 years after surgery.

Study Arms (2)

PSI group

we divided all patients into two groups according to their RSH in the final follow-up time: PSI group (RSH≥20mm)

Procedure: Selective thoracolumbar fusion (STLF) surgery

Non-PSI

we divided all patients into two groups according to their RSH in the final follow-up time: Non-PSI group (RSH≤20mm)

Procedure: Selective thoracolumbar fusion (STLF) surgery

Interventions

Selective thoracolumbar fusion (STLF) surgery PROCEDURE

Selective thoracolumbar fusion (STLF) surgery, is an established corrective surgical technique for spinal deformities with excellent outcomes over time

Non-PSI; PSI group

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• \- (i): diagnosed with Lenke 1/2 AIS;(ii).underwent the selective thoracolumbar fusion;

You may not qualify if:

• (i).were diagnosed with other types scoliosis(eg, congenital, neuromuscular) (ii).lacked preoperatively, immediately postoperatively, or follow-up time radiographic data.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Central Study Contacts

Fu tao Li, M.D

CONTACT

86-20-6278 7195; 1012095069@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 17, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

CN (1)