Nasal Bone FractureNCT07869563
Ultrasound-assisted Nasal Bone Fracture Reduction
A study testing Ultrasound-guided nasal bone fracture reduction and No ultrasound-guided nasal bone fracture reduction in people with Nasal Bone Fracture and Ultrasound, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 70 years
- Conditions the study is for
- Nasal Bone Fracture, Ultrasound
- What is being tested?
- Ultrasound-guided nasal bone fracture reduction and No ultrasound-guided nasal bone fracture reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2023to 1 Sep 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with nasal trauma within 2 weeks, accompanied by nasal deformity or nasal ventilation dysfunction.
Who cannot join
- Aged over 70 years or under 5 years, combined with orbital or intracranial injury, or with surgical contraindications.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 1 recruiting
- Active, not recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 3100
Hong-gang Duan
About this study
Official title: Development and Application of Musculoskeletal Ultrasound-assisted Visual Reduction Technology for Nasal Bone Fracture**
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.
- Conditions
- Nasal Bone Fracture, Ultrasound
- Being tested
- Ultrasound-guided nasal bone fracture reduction, No ultrasound-guided nasal bone fracture reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided nasal bone fracture reductionProcedure or surgery
Ultrasound-guided nasal bone fracture reduction
No ultrasound-guided nasal bone fracture reductionProcedure or surgery
No ultrasound-guided nasal bone fracture reduction
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound assist | Experimental | Ultrasound-guided nasal bone fracture reduction Receives: Procedure: Ultrasound-guided nasal bone fracture reduction |
| No ultrasound assist | Active comparator | No ultrasound assists nasal bone fracture reduction Receives: Procedure: No ultrasound-guided nasal bone fracture reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 weeks and 3months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Jan 2023
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Bone FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869563
- Sponsor's protocol ID
- IRB-2022-1287
- Status last verified
- Aug 2026
- First submitted
- 23 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided