- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05987150
Variation in Anisotropy of the Spinal Cord in Patients With Hyperkyphosis
Variation in Anisotropy of the Spinal Cord Around Apical Region in Patients With Hyperkyphosis: A Pilot Study Using Diffusion Tensor Imaging
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Jiang Su
-
Nanjing, Jiang Su, China, 210000
- Drum Tower Hospital of Nanjing University Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
preoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
preoperative
|
|
Sagittal deformity angular ratio (SDAR)
Time Frame: preoperative
|
Divided GK by the number of levels spanning the curve.
|
preoperative
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-398-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hyperkyphosis
-
Lincoln University CollegeCompleted
-
Halic UniversityMedipol University; Basaksehir Cam & Sakura Şehir HospitalRecruitingSpinal Curvatures | Scheuermann Disease | Hyperkyphosis, AdolescentTurkey
-
Istinye UniversityCompletedHyperkyphosisTurkey (Türkiye)
-
Istanbul University - Cerrahpasa (IUC)Completed
-
Pontificia Universidade Católica do Rio Grande...Financiadora de Estudos e ProjetosNot yet recruiting
-
Gazi UniversityCompleted
-
Istanbul University - CerrahpasaRecruitingExercise Therapy | Muscle Activation | Hyperkyphosis, Adolescent | Scapula; Deformity, AcquiredTurkey (Türkiye)
-
Sanko UniversityCompletedHyperkyphosis | ViscoelasticityTurkey (Türkiye)
-
Istanbul University - CerrahpasaNot yet recruitingHyperkyphosis, AdolescentTurkey (Türkiye)
-
Istituto Scientifico Italiano Colonna VertebraleRecruitingAdolescent Idiopathic Scoliosis | HyperkyphosisItaly
Clinical Trials on Variation in anisotropy of the Spinal Cord using diffusion tensor imaging
-
Assistance Publique - Hôpitaux de ParisUnknownHearing Loss | Encephalopathy | SUSAC's Syndrome | Retinal Artery Branch OcclusionsFrance
-
Bezmialem Vakif UniversityCompleted
-
Cambridge University Hospitals NHS Foundation TrustNational Institute for Health Research, United Kingdom; Wolfson Brain Imaging...RecruitingCervical Spondylosis With Myelopathy | Degenerative Cervical MyelopathyUnited Kingdom
-
University of MichiganWithdrawn
-
Fondation Ophtalmologique Adolphe de RothschildRecruitingTrigeminal Neuralgia | Microvascular Decompression Surgery | Diffusion Tensor ImagingFrance
-
Chinese University of Hong KongActive, not recruitingMultiple SclerosisHong Kong
-
Second Affiliated Hospital, School of Medicine,...Zhejiang UniversityRecruitingSpinal Cord Injuries (SCI)China
-
Yunnan Cancer HospitalRecruiting
-
Hospices Civils de LyonCompleted
-
Assoc. Prof. Jiri Kriz, MD, PhDRecruitingSpinal Cord Injuries | Autonomic DysreflexiaCzechia