UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036285
Receipt number 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 23:12:40

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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 or person

Institute

Hakodate Central General Hospital

Institute

Department

Personal name



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

Value
https://center6.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