Variation in Anisotropy of the Spinal Cord in Patients With Hyperkyphosis

Hyperkyphosis Clinical Trial

Official title:

Variation in Anisotropy of the Spinal Cord Around Apical Region in Patients With Hyperkyphosis: A Pilot Study Using Diffusion Tensor Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05987150
• Other study ID #: 2021-398-01
• Status: Completed
• Start date: July 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: August 2023
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 30, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 78 Years

Eligibility

Inclusion Criteria:

• diagnosis of hyperkyphosis;
• the apex located at the thoracal region (T1-T12);
• full DTI data;
• records of detailed and systematic neurological physical examination.

Exclusion Criteria:

• any case with active infection, tumor, or trauma;
• any cases of comorbidity of neurofibromatosis type I;
• any cases combined with spinal syringomyelia, split cord malformations or diastematomyelia, tethered cord syndrome;
• previous spinal surgery.

Related Conditions & MeSH terms

• Hyperkyphosis
• Kyphosis

Intervention

Radiation:
• Variation in anisotropy of the Spinal Cord using diffusion tensor imaging
All examinations were performed on a 3.0-T MRI machine with a 12-channel spine special coil (Ingenia CX, Philips Healthcare, Best, the Netherlands). The multi-sequence MRI protocol included conventional T1-weighted (sag & tra), T2-weighted (sag & tra), and DTI sequence.

Locations

Country	Name	City	State
China	Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiang Su

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional anisotropy (FA) values	Raw DTI data were postprocessed on FuncTool (GE) software. After an initial correction of geometric distortions, the color-coded FA maps were generated.	preoperative
Secondary	Global kyphosis (GK) in degrees	Measured on anteroposterior and lateral radiographs and defined as the angle from upper to lower most tilted end vertebrae.	preoperative
Secondary	Sagittal deformity angular ratio (SDAR)	Divided GK by the number of levels spanning the curve.	preoperative