Viewing Study NCT05987150


Ignite Creation Date: 2025-12-24 @ 5:01 PM
Ignite Modification Date: 2025-12-25 @ 2:41 PM
Study NCT ID: NCT05987150
Status: COMPLETED
Last Update Posted: 2023-08-15
First Post: 2023-08-04
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Variation in Anisotropy of the Spinal Cord in Patients With Hyperkyphosis
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Organization:

Study Overview

Official Title: Variation in Anisotropy of the Spinal Cord Around Apical Region in Patients With Hyperkyphosis: A Pilot Study Using Diffusion Tensor Imaging
Status: COMPLETED
Status Verified Date: 2023-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Spinal cord compression is commonly seen in patients with severe kyphosis. However, conventional morphologic magnetic resonance imaging (MRI) was unable to detect the damage in microstructural integrity of the spinal cord around the apical vertebrae in these patients. The aim of the study was to evaluate the neuronal metrics/microstructure of the spinal cord around apical region in patients with hyperkyphosis using diffusion tensor imaging (DTI).
Detailed Description: Spinal cord compression is commonly seen in patients with severe kyphosis. However, conventional morphologic magnetic resonance imaging (MRI) was unable to detect the damage in microstructural integrity of the spinal cord around the apical vertebrae in these patients. The aim of the study was to evaluate the neuronal metrics/microstructure of the spinal cord around apical region in patients with hyperkyphosis using diffusion tensor imaging (DTI).

Twenty-four patients with hyperkyphosis aged 46.1±22.8 years who underwent 3.0T MRI examination with DTI sequence were prospectively enrolled from July 2022 to January 2023. Patients were divided into three groups according to spinal cord/cerebrospinal fluid architecture (CSF) on sagittal-T2 MRI of the thoracic apex: Type A-circular cord with visible CSF, Type B-circular cord but no visible CSF at apical dorsal, and Type C-spinal cord deformed without intervening CSF. The Fractional Anisotropy (FA) values acquired from DTI were compared among different groups. Correlations between DTI parameters and global kyphosis (GK)/sagittal deformity angular ratio (SDAR) were evaluated using Pearson correlation coefficients.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: