UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018681 |
|---|---|
| Receipt number | 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 15:30:22 |
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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
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
hoshino717@gmail.com
Sponsor or person
Institute
Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021624
