Sound Conduction of Infant Hips

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

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).

Study Overview

• Status: Terminated
• Conditions: Developmental Dysplasia of the Hip
• Intervention / Treatment: Device: Acoustical Resonance Device

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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 6 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infants with developmental dysplasia of the hip; Infant participants putting on a device for 15 minutes to take different measurements of the hip	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
Active Comparator: Infants without developmental dysplasia of the hip; Infant participants putting on a device for 15 minutes to take different measurements of the hip	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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: University of Central Florida
• Investigators: Principal Investigator: Pablo Castaneda, MD, NYU Lagone Health

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Actual): October 6, 2023
• Study Completion (Actual): October 6, 2023

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Joint Dislocations; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
• Other Study ID Numbers: 21-01096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to study team members. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No