Sound Conduction of Infant Hips

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2023-10-06

Brief Summary

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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).

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Detailed Description

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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

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Developmental Dysplasia of the Hip

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Infants with developmental dysplasia of the hip

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

Group Type EXPERIMENTAL

Acoustical Resonance Device

Intervention Type 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

Infants without developmental dysplasia of the hip

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

Group Type ACTIVE_COMPARATOR

Acoustical Resonance Device

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.