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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009145
Receipt No. R000010720
Scientific Title Clinical trial of custom-made titanium for cervical spine fusion
Date of disclosure of the study information 2012/11/01
Last modified on 2019/07/31

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Basic information
Public title Clinical trial of custom-made titanium for cervical spine fusion
Acronym Clinical trial of custom-made titanium
Scientific Title Clinical trial of custom-made titanium for cervical spine fusion
Scientific Title:Acronym Clinical trial of custom-made titanium
Region
Japan

Condition
Condition cervical spondylotic myelopathy, cervical disc hernia, cervical ossification of posterior ligamentum flavum, cervical spondylotic radiculopathy
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the safty and efficacy of custom-made titanium as a spinal fusion device for degenerative cervical spine disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of adverse event and failure.
Improvement of preoperative symptoms.
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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Anterior cervical fusion
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Cervical spondylotic myelopathy, cervical disc hernia, cervical ossification of posterior ligamentum flavum, cervical spondylotic radiculopathy.

2) Good general status
Key exclusion criteria 1) No lumbar or thoracic spine disease
2) No collagen disease
3) No uncontrolable general disease
4) No malignacy
5) No psychological disease
6) No steroid treatment
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Fujibayashi
Organization Kyoto University Hospital
Division name Orthopaedic surgery
Zip code
Address Sakyo-ku, Shogoin Kawaharacho 54, Kyoto, Japan
TEL 075-761-3652
Email shfuji@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Fujibayashi
Organization Kyoto University Hospital
Division name Orthopaedic surgery
Zip code
Address Sakyo-ku, Shogoin Kawaharacho 54, Kyoto, Japan
TEL 075-761-3652
Homepage URL
Email shfuji@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization Grant-in-Aid for subject-solution-type development of medical instrument
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2012 Year 11 Month 01 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 No longer recruiting
Date of protocol fixation
2012 Year 10 Month 18 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 01 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
2012 Year 10 Month 18 Day
Last modified on
2019 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010720

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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