HyperkyphosisNCT05987150
Variation in Anisotropy of the Spinal Cord in Patients With Hyperkyphosis
An observational study of Hyperkyphosis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 11 to 78 years
- Conditions the study is for
- Hyperkyphosis
- What is being tested?
- Variation in anisotropy of the Spinal Cord using diffusion tensor imaging
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 78 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- diagnosis of hyperkyphosis;
- the apex located at the thoracal region (T1-T12);
- full DTI data;
- records of detailed and systematic neurological physical examination.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000
About this study
Official title: Variation in Anisotropy of the Spinal Cord Around Apical Region in Patients With Hyperkyphosis: A Pilot Study Using Diffusion Tensor Imaging
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.
- Conditions
- Hyperkyphosis
- Being tested
- Variation in anisotropy of the Spinal Cord using diffusion tensor imaging
- Medical subject headings
- Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variation in anisotropy of the Spinal Cord using diffusion tensor imagingRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Radiation: Variation in anisotropy of the Spinal Cord using diffusion tensor imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: preoperative
Secondary outcomes (2)
Global kyphosis (GK) in degrees
Measured on anteroposterior and lateral radiographs and defined as the angle from upper to lower most tilted end vertebrae.
Measured: preoperative
Sagittal deformity angular ratio (SDAR)
Divided GK by the number of levels spanning the curve.
Measured: preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jul 2022
- Primary completion31 Jan 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkyphosisStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987150
- Sponsor's protocol ID
- 2021-398-01
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variation in Anisotropy of the Spinal Cord Around Apical Region in Patients With Hyperkyphosis: A Pilot Study Using Diffusion Tensor Imaging
- ClinicalTrials.gov ID
- NCT05987150
- Acronym / sponsor ID
- 2021-398-01
- Conditions
- Hyperkyphosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type A | – | Radiation: Variation in anisotropy of the Spinal Cord using diffusion tensor imagingType A was defined as a round/oval spinal cord shape with visible cerebrospinal fluid (CSF) between the cord and the apical vertebrae. |
| Type B | – | Radiation: Variation in anisotropy of the Spinal Cord using diffusion tensor imagingType B was defined as a round/oval spinal cord shape with no CSF between the apical vertebrae and spinal cord. |
| Type C | – | Radiation: Variation in anisotropy of the Spinal Cord using diffusion tensor imagingType 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. |
Who may qualify
- Ages
- 11 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- diagnosis of hyperkyphosis;
- the apex located at the thoracal region (T1-T12);
- full DTI data;
- records of detailed and systematic neurological physical examination.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Variation in anisotropy of the Spinal Cord using diffusion tensor imagingAll 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. | Radiation | Type A, Type B, Type C |
Primary outcome
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.
2 secondary outcomes
Global kyphosis (GK) in degrees
Time frame: preoperative
Sagittal deformity angular ratio (SDAR)
Time frame: preoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperkyphosis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional anisotropy (FA) values (time frame: preoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.