UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Establishment of effective and efficient minimally invasive surgical treatment for fresh osteoporotic vertebral fracture with a poor prognostic factor - prospective multicenter intervention study -
Title of the study (Brief title)	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	Masatoshi Hoshino
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
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	Masatoshi Hoshino
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000021624