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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027479
Receipt No. 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 2017/05/24

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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
Middle name
Last name Akira ITOI
Organization Juntendo University Shizuoka Hospital
Division name orthopadic surgery
Zip code
Address Nagaoka 1129, Izunokuni-shi, Shizuoka, Japan
TEL 055-9480-3111
Email aitoi@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira ITOI
Organization Juntendo University Shizuoka Hospital
Division name orthopadic surgery
Zip code
Address Nagaoka 1129, Izunokuni-shi, Shizuoka, Japan
TEL 055-948-3111
Homepage URL
Email aitoi@juntendo.ac.jp

Sponsor
Institute Juntendo University Shizuoka Hospital orthopadic surgery
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 08 Day
Last follow-up date
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
2017 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031374

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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