UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000605 |
|---|---|
| Receipt number | R000000717 |
| Scientific Title | Clinical study on custom-made bone implants alpha-TCP-based novel bone implants with geometry that fits bone defects and internal structures efficient for bone tissue regeneration |
| Date of disclosure of the study information | 2007/02/09 |
| Last modified on | 2007/10/26 13:03:29 |
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Basic information
Public title
Clinical study on custom-made bone implants alpha-TCP-based novel bone implants with geometry that fits bone defects and internal structures efficient for bone tissue regeneration
Acronym
Clinical study on custom-made bone implants
Scientific Title
Clinical study on custom-made bone implants alpha-TCP-based novel bone implants with geometry that fits bone defects and internal structures efficient for bone tissue regeneration
Scientific Title:Acronym
Clinical study on custom-made bone implants
Region
| Japan |
Condition
Condition
Congenital, traumatic, post-operative or tumorous defects/deformations of unloaded bones in cranio-maxillofacial areas and limbs and trunks
Classification by specialty
| Orthopedics | Radiology | Oral surgery |
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm clinical safety and efficacy of custom made bone implants (3DB-01) based on alpha-TCP, which has been safely used in clinical settings
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Confirmation of safety and efficacy of custom-made bone implants (3DB-01)
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 | Maneuver |
Interventions/Control_1
Artificial bones molded by ink-jet printing techniques are implanted to congenital, traumatic, post-operative or tumorous defects/deformations of unloaded bones in cranio-maxillofacial areas and limbs and trunks
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
| 6 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases with congenital, traumatic, post-operative or tumorous defects/ deformations of unloaded bones in cranio-maxillofacial areas and limbs and trunks
Key exclusion criteria
1) Patients with complications including abnormal calcium metabolism or serious cardiac, hepatic or renal dysfunctions (grade 2 and grade 3 in the complication category)
2) Patients who have less-than-one-year prognoses of complications
3) Patients with severe complications who are not expected to endure tests necessary for clinical follow-up.
4) Patients with infections that may relapse.
5) Patients with collagen diseases.
6) Patients with histories of alcohol or drug dependency within the past 3 months
7) Patients with malignant neoplasms
8) Patients with possibile malignant neoplasms
9) Patients with proliferative diabetic retinopathy
10) Pregnant women, women suspected of being pregnant and breast-feeding women
11) Patients who cannot observe the instruction not to inflict excessive forces and burdens on affected areas after implantation and patients with mental disorders.
12) Patients who do not give informed consents
13) Patients who are judged to be inappropriate for the study by doctors in charge.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Takato |
Organization
The University of Tokyo Hospital
Division name
Division of Tissue Engineering
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
TEL
03-3815-5411(33714)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Tei/Ung-il Chung |
Organization
The University of Tokyo Hospital
Division name
Division of Tissue Engineering
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
TEL
03-3815-5411(37014)
Homepage URL
uiching-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital Division of Tissue Engineering
Institute
Department
Personal name
Funding Source
Organization
Funding for Development of Highly-advanced Medical Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2007 | Year | 02 | Month | 09 | 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
Date of protocol fixation
| 2006 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 02 | Month | 09 | Day |
Last modified on
| 2007 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000717
