Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059013) titled 'Clinical Evaluation of Mandibular Reconstruction Using Titanium Mesh Tray and Particulate Cancellous Bone and Marrow from Ilium and Tibia' on Oct. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Tsurumi University
Condition:
Condition - Mandibular Defect
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study clinically evaluates mandibular reconstruction using a custom-made titanium mesh tray and particulate cancellous bone and marrow harvested from the ilium or tibia.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - In patients with mandibular defects, reconstruction is carried out using a custom-made titanium mesh tray combined with autogenous PCBM from the ilium or tibia.
Eligibility:
Age-lower limit - 10
years-old
=
Gender - Male and Female
Key inclusion criteria - Mandibular reconstruction is indicated for patients aged 10 years and above, based on mandibular growth patterns and dental development.
Due to surgical invasiveness, the procedure is not recommended for individuals over 70 years of age.
The indication criteria are independent of gender.
Key exclusion criteria - Patients Who Declined Mandibular Reconstruction Using a Custom-made Titanium Mesh Tray and Particulate Cancellous Bone and Marrow from the Ilium or Tibia
Target Size - 250
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2013 Year 07 Month 01 Day
Date of IRB - 2013 Year 07 Month 26 Day
Anticipated trial start date - 2013 Year 07 Month 01 Day
Last follow-up date - 2033 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067491
Disclaimer: Curated by HT Syndication.
