NCT05188235

Sound Conduction of Infant Hips

Pilot Study on the Evaluation of Sound Conduction of Healthy Infant Hips and Those With Developmental Dysplasia of the Hip (DDH)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 1 Day – 6 Months
• Healthy volunteers: Accepted

Summary

The objective of this study is to collect data that will be used to later design a method for the early diagnosis of diagnosis of developmental dysplasia of the hip (DDH).

Detailed description

This will be a prospective study using an acoustic listening technique in combination with a standard clinical examination of DDH. For both the clinical cases and healthy children that are enrolled, that all subjects will have an ultrasound completed for comparison to the use of the studied tuning fork method. The gold standard is POCUS (point of care ultrasound as performed by the pediatric orthopedic surgeon). Collected data will be compared to POCUS as performed by an expert and this is standard of care. Healthy subjects will be referred for evaluation and found to be healthy on subsequent US.

Conditions

• Developmental Dysplasia of the Hip

Interventions

Type	Name	Description
DEVICE	Acoustical Resonance Device	Infants will be studied for 15 min using an electronic "tuning fork" to transmit sound through the hip from a point on the skin while transmitted sounds FDA-approved stethoscope

Timeline

• Start date: 2022-03-10
• Primary completion: 2023-10-06
• Completion: 2023-10-06
• First posted: 2022-01-12
• Last updated: 2024-11-04

Locations

1 site across 1 country: United States