Sound Conduction of Infant Hips

Not Applicable

Terminated

• Conditions: Developmental Dysplasia of the Hip
• Interventions: Device: Acoustical Resonance Device

• Registration Number: NCT05188235
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-12
• Study Start: 2022-03-10
• Primary Completion: 2023-10-06
• Study Completion: 2023-10-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infants without developmental dysplasia of the hip	Acoustical Resonance Device	Infant participants putting on a device for 15 minutes to take different measurements of the hip
Infants with developmental dysplasia of the hip	Acoustical Resonance Device	Infant participants putting on a device for 15 minutes to take different measurements of the hip

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States