UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060282 |
|---|---|
| Receipt number | R000068944 |
| Scientific Title | Longterm Observational Study of Resorbable Plate Assisted Suturectomy for Craniosynostosis |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/01/18 16:32:14 |
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Basic information
Public title
Longterm Observational Study of Resorbable Plate Assisted Suturectomy for Craniosynostosis
Acronym
Longterm Observational Study of Resorbable Plate Assisted Suturectomy
Scientific Title
Longterm Observational Study of Resorbable Plate Assisted Suturectomy for Craniosynostosis
Scientific Title:Acronym
Longterm Observational Study of Resorbable Plate Assisted Suturectomy
Region
| Japan |
Condition
Condition
Craniosynostosis
Classification by specialty
| Neurosurgery | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will follow patients who underwent resorbable plate assisted suturectomy for over 5 years postoperatively and evaluate intracranial volume and cranial morphology, bone regeneration and residual defects, and the presence and indications of reoperation. In syndromic cases, we will analyze midface growth and its implications for future reconstructive surgery.
Basic objectives2
Others
Basic objectives -Others
Craniosynostosis is a rare disorder that causes elevated intracranial pressure and craniofacial deformity, and conventional suturectomy is limited by early re-synostosis. At our institution, we temporarily cover the resected suture margins with resorbable plates to suppress re-synostosis and promote natural bone regeneration after resorption, and we will evaluate the clinical outcomes and efficacy of this approach.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Longitudinal change in intracranial volume (ICV) at pre-op, 3/6/12 months, then annually up to 5 years
Presence/absence of bone regeneration or residual cranial defects (imaging-based; CT)
Key secondary outcomes
Longitudinal change in cranial shape indices (e.g., Cephalic Index)
Intracranial volume,Cephalometric analysis,Clinical photographic measurements,Clinical findings (including complications)
Reoperation rate, timing, and indications
In syndromic cases, midface growth and implications for future reconstruction/fixation safety
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
Underwent or will undergo resorbable plate assisted suturectomy at our hospital
Clinically indicated imaging feasible pre or postoperatively
Key exclusion criteria
Anticipated inability to complete follow-up or obtain analyzable imaging
Deemed inappropriate by investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | DAISUKE |
| Middle name | |
| Last name | SAKAHARA |
Organization
Osaka City General Hospital
Division name
Plastic & Reconstructive Surgery
Zip code
5340021
Address
2-13-22 Miyakojima-hondori, Miyakojima-ku, Osaka City, Osaka
TEL
0669291221
d-sakahara@med.osakacity-hp.or.jp
Public contact
Name of contact person
| 1st name | DAISUKE |
| Middle name | |
| Last name | SAKAHARA |
Organization
Osaka City General Hospital
Division name
Plastic & Reconstructive Surgery
Zip code
5340021
Address
2-13-22 Miyakojima-hondori, Miyakojima-ku, Osaka City, Osaka
TEL
06-6929-1221
Homepage URL
d-sakahara@med.osakacity-hp.or.jp
Sponsor or person
Institute
Osaka City General Hospital
Institute
Department
Personal name
DAISUKE SAKAHARA
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City General Hospital
Address
Miyakojima center Bil, 2F, 5-15-21, Nakanocho, Miyakojima, Osaka
Tel
0669293269
xc0017@osakacity-hp.or.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
| 2026 | Year | 04 | 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
100
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2046 | Year | 12 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2046 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2046 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2046 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2046 | Year | 12 | Month | 31 | Day |
Other
Other related information
This study is observational. The subjects are patients with craniosynostosis who have undergone resorbable-plate-assisted suturectomy performed at our institution.
If meaningful results are obtained during the course of the study, we may report those interim findings at academic conferences or in medical journals.
Management information
Registered date
| 2026 | Year | 01 | Month | 07 | Day |
Last modified on
| 2026 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068944
