UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023208 |
|---|---|
| Receipt number | R000025862 |
| Scientific Title | Use of an Injectable Complex of Beta-Phosphate Granules, Hyaluronate, and Fibroblast Growth Factor-2 on Repair of Fracture with Bone Defects. |
| Date of disclosure of the study information | 2016/07/19 |
| Last modified on | 2016/07/17 19:29:21 |
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Basic information
Public title
Use of an Injectable Complex of Beta-Phosphate Granules, Hyaluronate, and Fibroblast Growth Factor-2 on Repair of Fracture with Bone Defects.
Acronym
Use of an Injectable Complex of Beta-TCP, Hyaluronate, and FGF-2 on Repair of Fracture with Bone Defects.
Scientific Title
Use of an Injectable Complex of Beta-Phosphate Granules, Hyaluronate, and Fibroblast Growth Factor-2 on Repair of Fracture with Bone Defects.
Scientific Title:Acronym
Use of an Injectable Complex of Beta-TCP, Hyaluronate, and FGF-2 on Repair of Fracture with Bone Defects.
Region
| Japan |
Condition
Condition
Fracture with Bone Defects
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluated effects of an injectable complex of beta-tricalcium phosphate (beta-TCP) granules, hyaluronate, and recombinant human fibroblast growth factor-2 (rhFGF-2) on repair of Fracture with Bone Defects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
X-ray and CT Evaluation of Bone Union
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
expanded access
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
| Medicine |
Interventions/Control_1
A complex of beta-TCP granules, hyaluronate, and rhFGF-2 in a cylinder is injected through the tip of the great trochanter to the base of the lesser trochanter during surgery under fluoroscopy in operation.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
And adaptation of the fracture cases with bone defect in the 20 years of age or older.
Key exclusion criteria
The following will be the key exclusion criteria.
Children
Malignant tumor present example
There is a history of allergy to beta-TCP, hyaluronic acid, and FGF-2
After more than four weeks after the injury
open fracture
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Soshi |
Organization
Department of Orthopedic Surgery, Jikei University School of Medicine
Division name
Department of Orthopedic Surgery
Zip code
Address
3-19-18, Nishishimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
kijijma@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Kijima |
Organization
Department of Orthopedic Surgery, Jikei University School of Medicine
Division name
Department of Orthopedic Surgery
Zip code
Address
3-19-18, Nishishimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
kijijma@jikei.ac.jp
Sponsor or person
Institute
Department of Orthopedic Surgery, Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopedic Surgery, Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 07 | Month | 19 | 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
| 2016 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 04 | 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
| 2016 | Year | 07 | Month | 17 | Day |
Last modified on
| 2016 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025862
