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CompletedNCT05987150Updated Aug 15, 2023

Variation in Anisotropy of the Spinal Cord in Patients With Hyperkyphosis

An observational study in Hyperkyphosis, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Completed at 1 site in China. Open to participants aged 11 Years to 78 Years. Per ClinicalTrials.gov, last updated 2023-08-15.

Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
24
Ages
11 Years to 78 Years
Sex
All
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Study 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).

Read the 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.

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Conditions studied

  • Hyperkyphosis

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03

In context

Kyphosis

131 studies on the registry are indexed under Kyphosis; 27 are open to participants now.

This study's enrollment of 24 is below the median of 67 across 49 observational studies indexed under Kyphosis.

Browse Kyphosis studies →

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
11 Years to 78 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

24 patients with hyperkyphosis aged 46.1±22.8 years who underwent 3.0T magnetic resonance imaging (MRI) examination with DTI sequence were prospectively enrolled.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
24 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Radiation: Variation in anisotropy of the Spinal Cord using diffusion tensor imaging

  • Type B

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

    Radiation: Variation in anisotropy of the Spinal Cord using diffusion tensor imaging

  • 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.

    Radiation: Variation in anisotropy of the Spinal Cord using diffusion tensor imaging

Interventions

  • RadiationVariation 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: preoperative

Secondary outcomes

  1. Global kyphosis (GK) in degrees

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

    Time frame: preoperative

  2. Sagittal deformity angular ratio (SDAR)

    Divided GK by the number of levels spanning the curve.

    Time frame: preoperative

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Study locations

1 site
  • Drum Tower Hospital of Nanjing University Medical School
    Nanjing, Jiang Su 210000, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05987150
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible party
Sponsor
First posted
Aug 14, 2023
Start date
Jul 1, 2022
Primary completion
Jan 31, 2023
Completion
Apr 30, 2023
Last update
Aug 15, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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