Variation in Anisotropy of the Spinal Cord in Patients With Hyperkyphosis

NCT ID: NCT05987150

Last Updated: 2023-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-04-30

Brief Summary

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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

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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.

Conditions

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Hyperkyphosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Type A

Type A was defined as a round/oval spinal cord shape with visible cerebrospinal fluid (CSF) between the cord and the apical vertebrae.

Variation in anisotropy of the Spinal Cord using diffusion tensor imaging

Intervention Type RADIATION

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.

Type B

Type B was defined as a round/oval spinal cord shape with no CSF between the apical vertebrae and spinal cord.

Variation in anisotropy of the Spinal Cord using diffusion tensor imaging

Intervention Type RADIATION

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.

Type C

Type C cord was defined as a spinal cord that is fattened/deformed by the vertebral body, with no visible CSF between the apex and the cord.

Variation in anisotropy of the Spinal Cord using diffusion tensor imaging

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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2021-398-01

Identifier Type: -

Identifier Source: org_study_id

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