UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049087 |
|---|---|
| Receipt number | R000055920 |
| Scientific Title | Study on the strength of SuperFIXSORB sheet of 0.3mm thickness after implantation in vivo. |
| Date of disclosure of the study information | 2022/10/03 |
| Last modified on | 2023/04/24 19:33:20 |
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Basic information
Public title
Study on the strength of SuperFIXSORB sheet of 0.3mm thickness after implantation in vivo.
Acronym
Study on the strength of SuperFIXSORB sheet of 0.3mm thickness after implantation in vivo.
Scientific Title
Study on the strength of SuperFIXSORB sheet of 0.3mm thickness after implantation in vivo.
Scientific Title:Acronym
Study on the strength of SuperFIXSORB sheet of 0.3mm thickness after implantation in vivo.
Region
| Japan |
Condition
Condition
Orbital fracture
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although there have been many reports on the use of bioabsorbable sheets made of forged composite of unsintered hydroxyapatite and poly-L-lactide (F-u-HA/PLLA) of 0.3mm thickness (SuperFIXSORB MX40, TEIJIN MEDICAL TECHNOLOGIES CO., LTD., Osaka, Japan) for orbital fractures, none have examined the actual strength of those implanted in human bodies.
The purpose of this study is to determine the viscosity-average molecular weight, crystallinity, and bending strength of specimens (SuperFIXSORB MX40 0.3mm-thick sheets) removed for clinical necessity, and to compare them with the results of in vitro degradation test to determine the degree of degradation and strength of the implants after clinical use.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Verify that the viscosity-averaged molecular weight of the removed specimen is not less than that of the same material in the in vitro degradation test. Although the timing of postoperative specimen removal varies from case to case, if the bending strength of the removed specimens at each time point is not less than the results of in vitro degradation tests, it can be assumed that implants placed in the human orbit also have sufficient bending strength at 12 months postoperatively.
Key secondary outcomes
Compare the crystallinity of the extracted specimens with that measured in in vitro degradation test.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have had a SuperFIXSORB 0.3mm thick sheet implanted in the orbit and then had the sheet removed due to clinical necessity.
Key exclusion criteria
Cases that might differ from the normal degradation process, such as infection or foreign body reaction, will be excluded.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Kawabata |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Plastic and Reconstructive Surgery
Zip code
650-0047
Address
2-1-1, Minatojimaminami-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-302-4321
tk9216@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Kawabata |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Plastic and Reconstructive Surgery
Zip code
650-0047
Address
2-1-1, Minatojimaminami-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-302-4321
Homepage URL
tk9216@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kobe City Medical Center 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
TEIJIN MEDICAL TECHNOLOGIES CO., LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe City Medical Center General Hospital Research Ethics Review Committee
Address
2-1-1, Minatojimaminami-cho, Chuo-ku, Kobe, Hyogo, Japan
Tel
078-302-5176
rinken@kcho.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
| 2022 | Year | 10 | Month | 03 | 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
10
Results
Decrease of viscosity-average molecular weight and bending strength resulted in slower progression in vivo than in vitro. Crystallinity varied, but the increasing trend was similar. F-u-HA/PLLA sheets were proved to retain more than 50% of their initial strength at 12 months postoperatively, which is enough to support orbital contents.
Results date posted
| 2023 | Year | 04 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Viscosity-average molecular weight, bending strength, and crystallinity.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective observational study to analyze the removed SuperFIXSORB 0.3 mm thick sheets from October 24, 2019 to June 30, 2022. However, any factors that may affect the natural degradation process of the sheets, such as infection or foreign body reaction, will be excluded. Specimens will be analyzed by TEIJIN MEDICAL TECHNOLOGIES CO., LTD. (specimens will be processed so that individuals cannot be identified).
Management information
Registered date
| 2022 | Year | 10 | Month | 01 | Day |
Last modified on
| 2023 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055920
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