NCT06737133

Brief Summary

Introduction: Nasal fractures are common components of the facial skeleton injuries. Nasal bone fractures are the most common type of facial fracture (1), and the third most common fracture of the human skeleton (2). Nasal fractures are frequently associated with cartilaginous and soft tissue injuries. The incidence of post- traumatic nasal deformity, if left untreated, varies from 14% to 50% (3).The management of nasal injuries since Maliniac's description of the management of nasal fractures in 1947 has seen several variations (3) . The functional and cosmetic problems arising may sometimes necessitate intricate surgical procedures to restore the anatomy. Due to constraints of resources and the range of services provided, these injuries are typically managed . Most commonly, nasal bone fractures are sustained in fights (34%), accidents (28%), and sports (23%). A 2009 study of 236 patients with facial fractures incurred while playing sports determined that fractures of the nasal bone were most common (4) . In children, nasal fractures are most commonly due to falls. In a study of 100 children with traumatic nasal deformity, Liu et al determined that such injuries were most often the result of sports-related trauma (28%), with accidental trauma (21%), interpersonal violence (10%), motor vehicle collisions (6%), and alcohol- related trauma (2%) being the next most common reasons for injury (5) . The possibility of child abuse should be considered in every child presenting with a nasal fracture The prognosis of nasal bone fracture is depend on: If NBFs are treated within correct time parameters, patients should anticipate a successful healing and proper nasal alignment. Communication between the surgeon, ENT physician, and primary care physician or emergency physician is crucial to the treatment plan (6). The greatest complications from reduction are malunion and cosmetic concerns. Incidence of complications is highest in bilateral fractures, comminuted fractures, and fractures with severe nasal septum deviation (7).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

November 25, 2024

Last Update Submit

December 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measure of the outer framework of the nose after trauma

    Early correction of nasal fractures to preserve the outer framework of the nose after trauma achieving the best result aiming to minimize rhinoplasty further on ,measuring the nasal bone length pre and postoperative

    One year and 3 months

Interventions

SurgeryPROCEDURE

Rhinoplasty

Eligibility Criteria

Age1 Day - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age ranged from since birth to 12 years old
  • Isolated nasal fracture
  • Presented from time of trauma up to 5 days

You may not qualify if:

  • Multiple facial fractures
  • Age more than 12 years old
  • Systemic diseases
  • Any hematological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

November 25, 2024

First Posted

December 17, 2024

Study Start

January 1, 2025

Primary Completion

January 1, 2026

Study Completion

March 1, 2026

Last Updated

December 17, 2024

Record last verified: 2024-12