Developmental Dysplasia of the Hip
Conditions
Brief 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.
Interventions
DEVICEAcoustical 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
Sponsors
University of Central Florida
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 6 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in soundwaves on the Actuator on patella, sensor on sacrum | Study visit 1 (Day 1) | 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 |
| Difference in soundwaves on the Actuator on patella, sensor on anterior superior iliac crest of pelvis | Study visit 1 (Day 1) | 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 |
| Difference in soundwaves on the Actuator on greater trochanter, sensor on sacrum | Study visit 1 (Day 1) | 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 |
| Difference in soundwaves on the Actuator on greater trochanter, sensor on anterior superior iliac crest | Study visit 1 (Day 1) | 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 |
Countries
United States
Outcome results
None listed