NCT05188235

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 10, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2023

Completed
Last Updated

November 4, 2024

Status Verified

October 1, 2024

Enrollment Period

1.6 years

First QC Date

December 20, 2021

Last Update Submit

October 31, 2024

Conditions

Developmental Dysplasia of the Hip

Outcome Measures

Primary Outcomes (4)

  • 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)

Study Arms (2)

Infants with developmental dysplasia of the hip

EXPERIMENTAL

Infant participants putting on a device for 15 minutes to take different measurements of the hip

Device: Acoustical Resonance Device

Infants without developmental dysplasia of the hip

ACTIVE COMPARATOR

Infant participants putting on a device for 15 minutes to take different measurements of the hip

Device: Acoustical Resonance Device

Interventions

Acoustical Resonance DeviceDEVICE

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

Infants with developmental dysplasia of the hipInfants without developmental dysplasia of the hip

Eligibility Criteria

Age1 Day - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Infants born prematurely
  • Infants greater than six months of age.
  • Nonviable neonates and neonates of uncertain viability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

Hip DislocationJoint DislocationsJoint DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Pablo Castaneda, MD

    NYU Lagone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2021

First Posted

January 12, 2022

Study Start

March 10, 2022

Primary Completion

October 6, 2023

Study Completion

October 6, 2023

Last Updated

November 4, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL, SAP
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.
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.

Locations

US(1)