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NCT Number: NCT05987150

Variation in Anisotropy of the Spinal Cord in Patients With Hyperkyphosis

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).

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Key information

Age range

11 year–78 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Variation in anisotropy of the Spinal Cord using diffusion tensor imaging

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.

Primary outcomes

  1. Fractional anisotropy (FA) values

    Time frame: preoperative

    Raw DTI data were postprocessed on FuncTool (GE) software. After an initial correction of geometric distortions, the color-coded FA maps were generated.

Secondary outcomes

  1. Global kyphosis (GK) in degrees

    Time frame: preoperative

    Measured on anteroposterior and lateral radiographs and defined as the angle from upper to lower most tilted end vertebrae.

  2. Sagittal deformity angular ratio (SDAR)

    Time frame: preoperative

    Divided GK by the number of levels spanning the curve.

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2023
Registry last updated
Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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