UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017354 |
|---|---|
| Receipt number | R000019163 |
| Scientific Title | Neurological deficit associated with osteoporotic vertebral fracture: evaluation of clinical features from a prospective multicenter study |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2021/05/06 06:43:02 |
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Basic information
Public title
Neurological deficit associated with osteoporotic vertebral fracture: evaluation of clinical features from a prospective multicenter study
Acronym
Neurological deficit associated with osteoporotic vertebral fracture: a prospective multicenter study
Scientific Title
Neurological deficit associated with osteoporotic vertebral fracture: evaluation of clinical features from a prospective multicenter study
Scientific Title:Acronym
Neurological deficit associated with osteoporotic vertebral fracture: a prospective multicenter study
Region
| Japan |
Condition
Condition
Osteoporotic vertebral fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical characteristics in epidemiology, symptoms and radiological findings in patients with osteoporotic vertebral fracture associated with neurological deficit
Basic objectives2
Others
Basic objectives -Others
Analysis of clinical features of osteoporotic vertebral fracture causing neurological deficit
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patients' background
Symptoms and neurological findings
Imaging findings
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Investigation of patients' background, symptoms, neurological deficits and imaging findings on plain x-ray, CT and MRI of the spine.
The investigation will be performed in patients having osteoporotic vertebral fracture associated with neurological deficit.
Interventions/Control_2
Investigation of patients' background, symptoms, neurological deficits and imaging findings on plain x-ray, CT and MRI of the spine.
The investigation will be performed in patients having osteoporotic vertebral fracture without neurological deficit.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria of patients with neurological deficit:
1. having osteoporotic vertebral fracture
2. having neurological symptom due to the fracture
3. having neurological sign
4. the neurological disturbance caused at the fracture site or at the upper or lower adjacent intervertebral level
5. regardless of presence of degenerative change in the lumbar spine such as spondylolisthesis and spinal canal narrowing
6. regardless of the treatment method
Inclusion criteria of patients without neurological deficit is to meet the criteria 1, 5 and 6 but not 2, 3, or 4 in above.
Key exclusion criteria
i) Neurological disturbance caused from other factor than ii) the fracture
iii) Fracture united and healed completely
iv) Secondary osteoporosis
v) Incapability of the imaging examination
vi) Without the patient's consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Haruo |
| Middle name | |
| Last name | Kanno |
Organization
Tohoku University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
9808574
Address
1-1 Seiryo-machi Aoba-ku Sendai
TEL
022-717-7245
kanno-h@isis.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Haruo |
| Middle name | |
| Last name | Kanno |
Organization
Tohoku University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
9808574
Address
1-1 Seiryo-machi Aoba-ku Sendai
TEL
022-717-7245
Homepage URL
kanno-h@isis.ocn.ne.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Tohoku University school of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Tohoku University school of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Independent Ethics Committee of Tohok University School of Medicine
Address
1-1 Seiryo-machi Aoba-ku Sendai
Tel
022-717-8007
med-kenkyo@bureau.tohoku.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
| 2015 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 30 | Day |
Last modified on
| 2021 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019163
| Research Plan | |
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| Registered date | File name |
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