UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009145 |
|---|---|
| Receipt number | 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 11:26:41 |
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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
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
shfuji@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010720
