UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022518 |
|---|---|
| Receipt number | R000025957 |
| Scientific Title | Can preoperative measurement of BMD using DXA and QCT be useful to predict the strength of pedicle screw fixation |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2019/02/13 11:29:10 |
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Basic information
Public title
Can preoperative measurement of BMD using DXA and QCT be useful to predict the strength of pedicle screw fixation
Acronym
Can preoperative measurement of BMD using DXA and QCT be useful to predict the strength of pedicle screw fixation
Scientific Title
Can preoperative measurement of BMD using DXA and QCT be useful to predict the strength of pedicle screw fixation
Scientific Title:Acronym
Can preoperative measurement of BMD using DXA and QCT be useful to predict the strength of pedicle screw fixation
Region
| Japan |
Condition
Condition
spinal disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Whether preoperative measurement of BMD usinf DXA and QCT can be useful to predict the strength of screw fixation and the loosening.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether insertional torque is independently affected by BMD measured by DXA and QCT.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurment of BMD using DXA and QCT.
Measurment of max screw insertion torque during operaton.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who plan to undergo spine fixing operation in our facility.
The patients who approves this study.
Key exclusion criteria
Age-lower limit is 20 years old.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Ishikawa |
Organization
Showa University School of medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
Department of Orthopaedic Surgery, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL
03-3784-8543
o9o16979696koji@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Ishikawa |
Organization
Showa University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL
03-3784-8543
Homepage URL
o9o16979696koji@gmail.com
Sponsor or person
Institute
Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science, Grants in Aid for Scientific Reserch, Scientific Research(C)" (General)
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
| 2016 | Year | 08 | Month | 01 | 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
The preoperative measurement of volumetric-BMD around the pedicle screw (PS-vBMD) was technically feasible and reliably predictive of screw insertional
torque during transpedicular fixation in a clinical setting.
Clin Spine Surg. 2018 Nov;31(9):E473-E480.
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
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 30 | Day |
Last modified on
| 2019 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025957
