UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027479 |
|---|---|
| Receipt number | R000031374 |
| Scientific Title | Impact of Adjacent Ankylosing Spinal Disorders on the Prognosis of Osteoporotic Vertebral Fractures: A multicenter prospective cohort study |
| Date of disclosure of the study information | 2017/05/29 |
| Last modified on | 2023/05/30 14:28:02 |
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Basic information
Public title
Impact of Adjacent Ankylosing Spinal Disorders on the Prognosis of Osteoporotic Vertebral Fractures: A multicenter prospective cohort study
Acronym
Impact of Adjacent Ankylosing Spinal Disorders on the Prognosis of Osteoporotic Vertebral Fractures: A multicenter prospective cohort study
Scientific Title
Impact of Adjacent Ankylosing Spinal Disorders on the Prognosis of Osteoporotic Vertebral Fractures: A multicenter prospective cohort study
Scientific Title:Acronym
Impact of Adjacent Ankylosing Spinal Disorders on the Prognosis of Osteoporotic Vertebral Fractures: A multicenter prospective cohort study
Region
| Japan |
Condition
Condition
Osteoporotic Vertebral Fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the risk of occurrence of pseudo-arthrosis due to ankyloses in the adjacent level to the osteoporotic vertebral fracture based on accurate diagnosis and prognostic evaluation.
Basic objectives2
Others
Basic objectives -Others
Pain, neurologic symptoms, back pain assessment method will be described.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The risk of pseudo-arthrosis in the 6 months after the onset.
Key secondary outcomes
Operation
Verbal Descriptor Scale of pain
Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ)
American Spinal Injury Association Impairment Scale
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who had a posterior wall injury due to a fresh osteoporotic vertebral body fracture in the 11th thoracic vertebra to 5th lumbar vertebra.
Key exclusion criteria
Patients who can not make appropriate assessment.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | ITOI |
Organization
Juntendo University Shizuoka Hospital
Division name
orthopadic surgery
Zip code
410-2295
Address
Nagaoka 1129, Izunokuni-shi, Shizuoka, Japan
TEL
0559483111
aitoi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | ITOI |
Organization
Juntendo University Shizuoka Hospital
Division name
orthopadic surgery
Zip code
4102295
Address
Nagaoka 1129, Izunokuni-shi, Shizuoka, Japan
TEL
0559483111
Homepage URL
aitoi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Shizuoka Hospital orthopadic surgery
Institute
Department
Personal name
Funding Source
Organization
Juntendo university Juntendo hospital orthopedic surgery
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
Department of Orthopaedic Surgery., Juntendo University. Shizuoka Hospital
Address
Nagaoka 1129, Izunokuni-shi, Shizuoka, Japan
Tel
0559483111
aitoi@juntendo.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
| 2017 | Year | 05 | Month | 29 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular
Management information
Registered date
| 2017 | Year | 05 | Month | 24 | Day |
Last modified on
| 2023 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031374
