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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003379
Receipt No. 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

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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
Email 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
Email kato.orth@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University, Graduate School, Dept. of Orthopaedic Surgery
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004002

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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