UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051766 |
|---|---|
| Receipt number | R000059080 |
| Scientific Title | Examination of total vertebral ossification in patients with OPLL using CT |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/07/31 17:46:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination of total vertebral ossification in patients with OPLL using CT
Acronym
Examination of total vertebral ossification in patients with OPLL using CT
Scientific Title
Examination of total vertebral ossification in patients with OPLL using CT
Scientific Title:Acronym
Examination of total vertebral ossification in patients with OPLL using CT
Region
| Japan |
Condition
Condition
spinal ligament ossification
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ossification of the posterior longitudinal ligament is most common in the cervical spine, but is known to occur in other sites as well. However, the actual situation is not clear. The significance of this study is to conduct a large-scale survey of the ossification of the posterior longitudinal ligament of the entire spine at multiple centers, and to raise the awareness of physicians in charge of diagnosis and treatment of this disease.
In addition, we investigated the frequency and actual state of ossification of the posterior longitudinal ligament in the entire spine using cervical spine plain X-ray and CT, and compared the characteristics of patients with extensive ossification of the posterior longitudinal ligament with cervical spondylosis and healthy subjects. The purpose is to consider
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
X-ray evaluation
OPLL type classification
CT evaluation
Examine the presence or absence of ossified foci in each vertebral body and between vertebrae using sagittal view and axial view of the entire spine. Regarding CT imaging, three examiners in the team are in charge independently and tally the results. The control group will not be included in the X-ray and CT evaluations.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with spinal ligament ossification (posterior longitudinal ligament ossification, ligamentum flavum ossification) on plain X-ray
Patients with cervical spondylosis who have spinal cord compression on cervical spine MRI as a control group
Key exclusion criteria
Patients who do not consent
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | YOSHIHARU |
| Middle name | |
| Last name | KAWAGUCHI |
Organization
Toyama Univ
Division name
orthopedics
Zip code
930-0152
Address
Toyama-ken Toyama-shi Sugitani 2630
TEL
+81764347353
zenji@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | YOSHIHARU |
| Middle name | |
| Last name | KAWAGUCHI |
Organization
Toyama Univ
Division name
orthopedics
Zip code
930-0152
Address
Toyama-ken Toyama-shi Sugitani 2630
TEL
+81764347353
Homepage URL
zenji@med.u-toyama.ac.jp
Sponsor or person
Institute
Toyama Univ
Institute
Department
Personal name
Funding Source
Organization
Toyama Univ
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Toyama Ethics Review Committee
Address
Toyama-ken Toyama-shi Sugitani 2630
Tel
0764347353
rinri@adm.u-toyama.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2013 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As it concerns general practice, this study will not result in any harm to the patient.
Management information
Registered date
| 2023 | Year | 07 | Month | 31 | Day |
Last modified on
| 2023 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059080
