Sound Conduction of Infant Hips

Study Overview
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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).

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.

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

Conditions
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Developmental Dysplasia of the Hip

Intervention / Treatment
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* Device: Acoustical Resonance Device


Participation Criteria
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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. Exclusion Criteria: Infants born prematurely Infants greater than six months of age. Nonviable neonates and neonates of uncertain viability

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infants with developmental dysplasia of the hip<br>Infant participants putting on a device for 15 minutes to take different measurements of the hip | Device: Acoustical Resonance Device<br>* 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<br>|
| Active Comparator: Infants without developmental dysplasia of the hip<br>Infant participants putting on a device for 15 minutes to take different measurements of the hip | Device: Acoustical Resonance Device<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in soundwaves on the Actuator on patella, sensor on sacrum | Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings | Study visit 1 (Day 1) | 
| Difference in soundwaves on the Actuator on patella, sensor on anterior superior iliac crest of pelvis | Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings | Study visit 1 (Day 1) | 
| Difference in soundwaves on the Actuator on greater trochanter, sensor on sacrum | Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings | Study visit 1 (Day 1) | 
| Difference in soundwaves on the Actuator on greater trochanter, sensor on anterior superior iliac crest | Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings | Study visit 1 (Day 1) |