Sound Conduction of Infant Hips

Developmental Dysplasia of the Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05188235
• Other study ID #: 21-01096
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: NYU Langone Health
• Contact: Pablo Castaneda, MD
• Phone: (212) 598-6624
• Email: Pablo.Castaneda[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Developmental Dysplasia of the Hip
• Hip Dislocation, Congenital

Intervention

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

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	University of Central Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)