NCT07869563

Brief Summary

Clinical Trial Abstract Nasal bone fracture is the most common traumatic disease in otorhinolaryngology, which adversely affects nasal appearance and physiological function. Traditional closed reduction relies merely on visual observation and palpation without objective intraoperative evaluation, often leading to insufficient reduction in comminuted, overlapping, or severely swollen fractures and residual nasal deformity. Musculoskeletal ultrasound features real-time dynamic imaging, radiation-free performance, and convenient operation, enabling visualized and precise fracture reduction. However, conventional ultrasound imaging for nasal bones is compromised by air interference due to the protruding nasal structure. This study aims to determine the optimal scanning parameters and suitable coupling agents for high-quality nasal bone imaging by enrolling healthy volunteers and fracture patients. Furthermore, it compares operative duration, postoperative CT scores, and physician and patient satisfaction between traditional reduction and ultrasound-assisted reduction groups. This study intends to establish a standardized intraoperative ultrasound-assisted nasal bone reduction protocol to improve reduction accuracy and clinical satisfaction.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
35mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
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

Study Progress57%
Jan 2023Sep 2029

Study Start

First participant enrolled

January 1, 2023

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

October 9, 2026

Status Verified

August 1, 2026

Enrollment Period

6.7 years

First QC Date

September 23, 2026

Last Update Submit

October 7, 2026

Conditions

Nasal Bone FractureUltrasound

Outcome Measures

Primary Outcomes (2)

  • Change in patient satisfaction with nasal appearance and function assessed by Visual Analogue Scale

    Patient satisfaction regarding nasal function and nasal cosmetic appearance measured by Visual Analogue Scale (VAS). VAS ranges from 0 (completely satisfied) to 10 (completely dissatisfied). Outcome is the change from baseline in VAS score.

    2 weeks and 3months after surgery

  • Change in physician-rated nasal appearance assessed by a standardized objective nasal appearance scale

    Physician-rated nasal cosmetic appearance assessed by two independent, blinded otolaryngologists using the standardized objective nasal appearance scale. The scale evaluates nasal dorsal alignment, dorsal contour, tip position, nasal symmetry, and overall deformity; each item scores from 0 to 3, total score ranges from 0 to 15, with higher scores indicating greater aesthetic impairment. The outcome is the change from baseline in the total objective appearance score.

    2 weeks and 3months after surgery

Study Arms (2)

Ultrasound assist

EXPERIMENTAL

Ultrasound-guided nasal bone fracture reduction

Procedure: Ultrasound-guided nasal bone fracture reduction

No ultrasound assist

ACTIVE COMPARATOR

No ultrasound assists nasal bone fracture reduction

Procedure: No ultrasound-guided nasal bone fracture reduction

Interventions

Ultrasound-guided nasal bone fracture reductionPROCEDURE

Ultrasound-guided nasal bone fracture reduction

Ultrasound assist
No ultrasound-guided nasal bone fracture reductionPROCEDURE

No ultrasound-guided nasal bone fracture reduction

No ultrasound assist

Eligibility Criteria

Age5 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with nasal trauma within 2 weeks, accompanied by nasal deformity or nasal ventilation dysfunction.

You may not qualify if:

  • Aged over 70 years or under 5 years, combined with orbital or intracranial injury, or with surgical contraindications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

ACTIVE NOT RECRUITING

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 3100, China

RECRUITING

Central Study Contacts

Hong-gang Duan, doctor

CONTACT

134291248322314061@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2026

First Posted

October 9, 2026

Study Start

January 1, 2023

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

October 9, 2026

Record last verified: 2026-08

Locations

CN(2)