UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003379 |
|---|---|
| Receipt number | R000004002 |
| Scientific Title | Development of minimally invasive treatments for Osteoporotic vertebra fractures |
| Date of disclosure of the study information | 2010/03/31 |
| Last modified on | 2018/10/12 01:38:48 |
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Basic information
Public title
Development of minimally invasive treatments for Osteoporotic vertebra fractures
Acronym
Development of minimally invasive treatments for Osteoporotic vertebra fractures
Scientific Title
Development of minimally invasive treatments for Osteoporotic vertebra fractures
Scientific Title:Acronym
Development of minimally invasive treatments for Osteoporotic vertebra fractures
Region
| Japan |
Condition
Condition
osteoporotic vertebra fractures
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
With Japanese Orthopaedic Association we would like to decide which osteoporotic vertebra fracture patients should be taken operation and develop the valid and safe minimally invasive treatments for such patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
JOA-BPEQ
VAS
SF-36
image findings (X-ray, CT, MRI)
neurological findings
side effects
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Vertebroplasty using CPC (calcium phosphate cement) with General anesthesia (Kochi Univ.)
Interventions/Control_2
Vertebroplasty using CPC (calcium phosphate cement) by uromatic balloon with General anesthesia (Osaka city Univ.)
Interventions/Control_3
Percutaneous Vertebroplasty using CPC (calcium phosphate cement) with local anesthesia (Tokyo Medical and Dental Univ.)
Interventions/Control_4
Vertebroplasty using HA (Hydroxyapatite) with General anesthesia (Nihon Univ.)
Interventions/Control_5
Percutaneous Vertebroplasty using PMMA (polymethylmethacrylate) with general anesthesia (Hakodate Central Hosp.)
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
1.Low back pain continuing >8weeks
2.Osteoporotic vertebra non-union fracture found by MRI or X-ray
3.Diagnosed as Primary osteoporosis
4.Women and Men
5.Don't care of L/E paralysis
6.With informed consent
Key exclusion criteria
1.pathological fractures
2.suffering with cancer
3.enrolled in a study at the other osteoporotic clinical trials
4.Impossible to be taken MRI
5.Impossible to walk before this porotic fracture
6.Bedridden or Senile persons
7.Considered not to be suitable with this study
8.With serious complications
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Shinomiya |
Organization
Tokyo Medical and Dental University, Graduate School
Division name
Dept. of Orthopaedic Surgery
Zip code
Address
Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5279
kato.orth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Kato |
Organization
Tokyo Medical and Dental University, Graduate School
Division name
Dept. of Orthopaedic Surgery
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5803-5279
Homepage URL
kato.orth@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University, Graduate School, Dept. of Orthopaedic Surgery
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
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
久留米大学附属病院（福岡県）、高知大学附属病院（高知県）、大阪市立大学附属病院（大阪府）、杏林大学附属病院、東京医科歯科大学附属病院、日本大学板橋病院、慶応義塾大学附属病院（以上、東京都）函館中央病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 31 | 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
| 2009 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 25 | Day |
Last modified on
| 2018 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004002
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
