Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060282) titled 'Longterm Observational Study of Resorbable Plate Assisted Suturectomy for Craniosynostosis' on April 1.
Study Type:
Observational
Primary Sponsor:
Institute - Osaka City General Hospital
Condition:
Condition - Craniosynostosis
Classification by malignancy - Others
Genomic information - NO
Objective:
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
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 Size - 100
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068944
Disclaimer: Curated by HT Syndication.
