Developmental Dysplasia of the HipNCT05188235
Sound Conduction of Infant Hips
A study testing Acoustical Resonance Device in people with Developmental Dysplasia of the Hip, run by NYU Langone Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 day to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Developmental Dysplasia of the Hip
- What is being tested?
- Acoustical Resonance Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2022to 6 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Infants born prematurely
- Infants greater than six months of age.
- Nonviable neonates and neonates of uncertain viability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Developmental Dysplasia of the Hip
- Being tested
- Acoustical Resonance Device
- Medical subject headings
- Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Infants with developmental dysplasia of the hip | Experimental | Infant participants putting on a device for 15 minutes to take different measurements of the hip Receives: 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 Receives: Device: Acoustical Resonance Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Study visit 1 (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start10 Mar 2022
- Primary completion6 Oct 2023
- Study completion6 Oct 2023
Why it stopped: Study terminated upon departure of PI from Sponsoring Institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Dysplasia of the HipStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Central Florida
- Responsible party
- Sponsor
- Investigators
- Pablo Castaneda, MD, Principal investigator, NYU Lagone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188235
- Sponsor's protocol ID
- 21-01096
- Status last verified
- Oct 2024
- First submitted
- 20 Dec 2021
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Evaluation of Sound Conduction of Healthy Infant Hips and Those With Developmental Dysplasia of the Hip (DDH)
- ClinicalTrials.gov ID
- NCT05188235
- Acronym / sponsor ID
- 21-01096
- Conditions
- Developmental Dysplasia of the Hip
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated upon departure of PI from Sponsoring Institution.
- Enrolment
- 61 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- University of Central Florida
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants with developmental dysplasia of the hip | Experimental | Device: Acoustical Resonance DeviceInfant participants putting on a device for 15 minutes to take different measurements of the hip |
| Infants without developmental dysplasia of the hip | Active comparator | Device: Acoustical Resonance DeviceInfant participants putting on a device for 15 minutes to take different measurements of the hip |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Infants born prematurely
- Infants greater than six months of age.
- Nonviable neonates and neonates of uncertain viability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acoustical Resonance DeviceInfants 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 | Device | Infants with developmental dysplasia of the hip, Infants without developmental dysplasia of the hip |
Primary outcome
Difference in soundwaves on the Actuator on patella, sensor on sacrum
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study was stopped early (reason given: Study terminated upon departure of PI from Sponsoring Institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Related trials for Developmental Dysplasia of the Hip
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Recruiting
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Osteoarthritis, Traumatic Arthritis
Not yet recruitingObservational study
3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
Active, not recruitingObservational study
The Medacta Quadra-P Anteverted Study
Arthrosis, Traumatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Castaneda, MD principal investigator
NYU Lagone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acoustical Resonance Device in people with Developmental Dysplasia of the Hip, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated upon departure of PI from Sponsoring Institution.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in soundwaves on the Actuator on patella, sensor on sacrum (time frame: Study visit 1 (Day 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.