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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018681
Receipt No. R000021624
Scientific Title Establishment of effective and efficient minimally invasive surgical treatment for fresh osteoporotic vertebral fracture with a poor prognostic factor - prospective multicenter intervention study -
Date of disclosure of the study information 2015/08/14
Last modified on 2018/08/16

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Basic information
Public title Establishment of effective and efficient minimally invasive surgical treatment for fresh osteoporotic vertebral fracture with a poor prognostic factor
- prospective multicenter intervention study -
Acronym Early stage surgical intervention study for fresh OVF
Scientific Title Establishment of effective and efficient minimally invasive surgical treatment for fresh osteoporotic vertebral fracture with a poor prognostic factor
- prospective multicenter intervention study -
Scientific Title:Acronym Early stage surgical intervention study for fresh OVF
Region
Japan

Condition
Condition fresh osteoporotic vertebral fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of minimally invasive surgery treatment(Balloon KyphoPlasty) for fresh osteoporotic vertebral fracture with a poor prognosis factor
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ADL impairment at 6 months
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Balloon KyphoPlasty
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
65 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria 1) osteoporotic vertebral fracture
2) Patients that can be planned surgical medical treatment within the onset 8 weeks
3) 65 years of age or older at the time of obtaining informed consent
4) poor prognostic factor in MRI findings (Diffuse low intensity or Confined high intensity in the T2 weighted image)
Key exclusion criteria 1) In the case of fractures difficult to use "KYPHON BKP system" (pedicle fracture and flattened vertebral, severe bone defect of posterior wall of the vertebral body, etc.)
2) a severe brain and cardiopulmonary vascular disease
3) systemic infection or local infection of fractured vertebral body
4) a hemorrhagic diathesis
5) a history of hypersensitivity to bone cement or contrast agent
6) dementia
7) malignant tumors
8) a lower limb paralysis or bladder rectal disorder
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Hoshino
Organization Osaka City University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL 06-6645-3851
Email hoshino717@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Masatoshi Hoshino
Organization Osaka City University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL 06-6645-3851
Homepage URL
Email hoshino717@gmail.com

Sponsor
Institute Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2015 Year 08 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

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
2015 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 14 Day
Last modified on
2018 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021624

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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