Ultrasound-assisted Nasal Bone Fracture Reduction

Condition(s) studied

Investigational drug(s) / intervention(s)

Ultrasound-guided nasal bone fracture reduction: Ultrasound-guided nasal bone fracture reduction

No ultrasound-guided nasal bone fracture reduction: No ultrasound-guided nasal bone fracture reduction

Study 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.

Eligibility

Primary outcome measure(s)

• Change in patient satisfaction with nasal appearance and function assessed by Visual Analogue Scale — 2 weeks and 3months after surgery
  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.
• Change in physician-rated nasal appearance assessed by a standardized objective nasal appearance scale — 2 weeks and 3months after surgery
  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.

Trial sites (2)

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

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