Sound Conduction of Infant Hips

NYU Langone Health

Status: Terminated

Conditions: Developmental Dysplasia of the Hip

Treatments: Device: Acoustical Resonance Device

Study type: Interventional

Funder types: Other

Identifiers

NCT05188235

21-01096

Details and patient eligibility

About

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).

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 1 day to 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Infants included in this study must be born at full term with a gestational age of 0-6 months
• Infants of both genders will be included
• Infants must have been screened for DDH.

Exclusion criteria

• Infants born prematurely
• Infants greater than six months of age.
• Nonviable neonates and neonates of uncertain viability

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Infants with developmental dysplasia of the hip

Experimental group

Description:

Infant participants putting on a device for 15 minutes to take different measurements of the hip

Treatment:

Device: Acoustical Resonance Device

Infants without developmental dysplasia of the hip

Active Comparator group

Description:

Infant participants putting on a device for 15 minutes to take different measurements of the hip

Treatment:

Device: Acoustical Resonance Device