Not provided
Not provided
Not provided
Not provided
Not provided
Study terminated upon departure of PI from Sponsoring Institution.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Central Florida | OTHER |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infants with developmental dysplasia of the hip | Experimental | Infant participants putting on a device for 15 minutes to take different measurements of the hip |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acoustical Resonance Device | 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 |
| 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pablo Castaneda, MD | NYU Lagone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
Not provided
Not provided
| ID | Term |
|---|---|
| D000082602 | Developmental Dysplasia of the Hip |
| ID | Term |
|---|---|
| D006617 | Hip Dislocation |
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D009139 |
| Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |