UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of minimally invasive treatments for Osteoporotic vertebra fractures
Title of the study (Brief title)	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	Kenichi Shinomiya
Organization	Tokyo Medical and Dental University, Graduate School
Division name	Dept. of Orthopaedic Surgery
Address	Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5279
Email	kato.orth@tmd.ac.jp

Public contact
Name of contact person	Tsuyoshi Kato
Organization	Tokyo Medical and Dental University, Graduate School
Division name	Dept. of Orthopaedic Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 05 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000004002