Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT05188235
Status:
TERMINATED
Last Update Posted:
2024-11-04
First Post:
2021-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sound Conduction of Infant Hips
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official Title:
Pilot Study on the Evaluation of Sound Conduction of Healthy Infant Hips and Those With Developmental Dysplasia of the Hip (DDH)
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated upon departure of PI from Sponsoring Institution.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: