Variation in Anisotropy of the Spinal Cord in Patients With Hyperkyphosis

NCT05987150 | Completed

• 1 other identifier: 2021-398-01
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Hyperkyphosis

Outcome Measures

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.

  preoperative

Secondary Outcomes (2)

• Global kyphosis (GK) in degrees

  preoperative

• Sagittal deformity angular ratio (SDAR)

  preoperative

Study Arms (3)

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

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.

Type A; Type B; Type C

Eligibility Criteria

• Age: 11 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Kyphosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: July 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: April 30, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)