Tokyo, Nov. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059702) titled 'Complication Analysis of Retroauricular Approach in the Management of Condylar Head and Neck Fractures' on Nov. 8.
Study Type:
Observational
Primary Sponsor:
Institute - West China Hospital of Stomatology, Sichuan University
Condition:
Condition - condylar fracture ORIF via retroauricular approach
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Evaluation of the safety and complications of the retroauricular approach in condylar fracture surgery.
Basic objectives2 - Safety
Eligibility:
Age-lower limit - 9
years-old
Gender - Male and Female
Key inclusion criteria - (1) Clinically and radiographically confirmed middle or high condylar fractures;
(2) Underwent open reduction and internal fixation of the condylar fracture via a retroauricular approach;
(3) No previous surgical treatment in the maxillofacial region;
(4) Age between 9 and 65 years.
Key exclusion criteria - (1) Lost to follow-up;
(2) Incomplete medical records, missing key information such as postoperative complications or details of modified surgical procedures;
(3) Underwent other surgeries involving the temporomandibular joint region during the follow-up period;
(4) History of otitis media, external auditory canal inflammation, or congenital/developmental disorders;
(5) Preexisting temporomandibular joint disorder prior to trauma.
Target Size - 16
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 03 Month 01 Day
Date of IRB - 2024 Year 11 Month 04 Day
Anticipated trial start date - 2024 Year 03 Month 15 Day
Last follow-up date - 2025 Year 05 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068284
Disclaimer: Curated by HT Syndication.
