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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036285
Receipt No. R000030890
Scientific Title examination of bone turnover markers in spinal fusion surgery
Date of disclosure of the study information 2019/03/25
Last modified on 2019/03/24

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Basic information
Public title examination of bone turnover markers in spinal fusion surgery
Acronym examination of bone turnover markers in spinal fusion surgery
Scientific Title examination of bone turnover markers in spinal fusion surgery
Scientific Title:Acronym examination of bone turnover markers in spinal fusion surgery
Region
Japan

Condition
Condition degenerative lumbar spinal diseases
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To demonstrate the dynamics of bone metabolic markers after lumbar spinal fusion
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bone metabolic markers (BAP, P1NP, OC and TRACP-5b) were monitored for 1-year after lumbar spinal fusion
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
30 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria One- or two-level PLIF/TLIF
Aged from 30 to 79 years
Non-osteoporosis
Key exclusion criteria Previous spinal fusion surgery
Previous fracture within one year
Collagen disease
Chronic kidney disease (eGFR<30mL/min/1.73m2)
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Ryota
Middle name
Last name Hyakkan
Organization Hakodate Central General Hospital
Division name Orthopaedics
Zip code 040-8585
Address Honcho 33-2, Hakodate City, Hokkaido
TEL 09026993173
Email ryota324@live.jp

Public contact
Name of contact person
1st name Ryota
Middle name
Last name Hyakkan
Organization Hakodate Central General Hospital
Division name Orthopaedics
Zip code 040-8585
Address Honcho 33-2, Hakodate City, Hokkaido
TEL 0138521231
Homepage URL
Email ryota324@live.jp

Sponsor
Institute Hakodate Central General Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hakodate Central General Hospital
Address Honcho 33-2, Hakodate City, Hokkaido
Tel 0138521231
Email ryota324@live.jp

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
2019 Year 03 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Open public recruiting
Date of protocol fixation
2017 Year 05 Month 20 Day
Date of IRB
2017 Year 05 Month 20 Day
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 03 Month 24 Day
Last modified on
2019 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030890

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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