UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Can preoperative measurement of BMD using DXA and QCT be useful to predict the strength of pedicle screw fixation
Title of the study (Brief title)	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	Koji Ishikawa
Organization	Showa University School of medicine
Division name	Department of Orthopaedic Surgery
Address	Department of Orthopaedic Surgery, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL	03-3784-8543
Email	o9o16979696koji@gmail.com

Public contact
Name of contact person	Koji Ishikawa
Organization	Showa University School of Medicine
Division name	Department of Orthopaedic Surgery
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL	03-3784-8543
Homepage URL
Email	o9o16979696koji@gmail.com

Sponsor
Institute	Showa University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025957