Scoliosis IdiopathicNCT03222739
Ultrasound for Scoliosis Diagnostic Evaluation
A study testing Ultrasound in people with Scoliosis Idiopathic and Scoliosis; Juvenile, run by Children's National Research Institute at 1 site in United States.
Trial summary
Scoliosis is a complex 3-dimensional deformity of the spine. It may occur at any time throughout growth and development and is typically detected through x-ray imaging. Although effective at visualizing a curve, x-ray imaging is costly and may expose children to potentially harmful ionizing radiation. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Scoliosis Idiopathic, Scoliosis; Juvenile
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2018to 6 Dec 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients ages 7-17 years who present to Dr. Matthew Oetgen in the Department of Orthopaedic Surgery \& Sports Medicine for clinical evaluation of scoliosis,
- Scoliosis curve type to include adolescent idiopathic (AIS) or juvenile, and
- Have x-rays taken as part of clinical evaluation
Who cannot join
- Not willing or able to provide consent, or
- Had x-rays taken at an outside facility, or
- Any underlying neuromuscular condition or syndrome and congenital deformities
Trial locations and contacts
1 site in 1 country.
Matthew Oetgen, MD contact
United States1 site, 1 recruiting
- Recruiting
Children's National Health System
Washington D.C., District of Columbia, 20011
Jonise
About this study
Official title: Slicer+PLUS: Collaborative, Open-source Software for Ultrasound Analysis
Scoliosis is a complex 3-dimensional deformity of the spine. It may occur at any time throughout growth and development and is typically detected through x-ray imaging. Although effective at visualizing a curve, x-ray imaging is costly and may expose children to potentially harmful ionizing radiation. This is a 30 patient study to evaluate the reliability of ultrasound, an imaging technique without radiation, to effectively measure scoliosis deformities compared to the gold-standard of x-ray.
Read the detailed description
All patients who present to Children's National Medical Center for initial evaluation of idiopathic or juvenile scoliosis will be approached.
- Conditions
- Scoliosis Idiopathic, Scoliosis; Juvenile
- Being tested
- Ultrasound
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
An industry standard ultrasound will be fitted with a self-tracking probe to track along the spine. The ultrasound will be performed three (3) times along the spine at initial consultation for scoliosis.
| Study group | Role | What they receive |
|---|---|---|
| Device Arm | Other | This is a single arm study comparing an ultrasound with the industry standard of x-ray to detect and monitor scoliosis curvature. Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging
Ability of the ultrasound to produce a radiographic measurement (e.g. coronal spinal curvature, coronal spinal rotation) within the variability of the gold standard of x-ray
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start14 Mar 2018
- Primary completion6 Dec 2023 (estimated)
- Study completion6 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm unblinded group of patients will receive ultrasound imaging of spine.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Kitware, Inc., National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Principal investigator, Kevin Cleary, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222739
- Sponsor's protocol ID
- Pro8456
- Other IDs
- R01EB021396-01A1
- Status last verified
- Jan 2023
- First submitted
- 13 Jul 2017
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slicer+PLUS: Collaborative, Open-source Software for Ultrasound Analysis
- ClinicalTrials.gov ID
- NCT03222739
- Acronym / sponsor ID
- Pro8456
- Conditions
- Scoliosis Idiopathic, Scoliosis; Juvenile
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- Kitware, Inc., National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 6 Dec 2023 (estimated)
- Study completion
- 6 Dec 2023 (estimated)
- First posted
- 19 Jul 2017 (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.
Scoliosis is a complex 3-dimensional deformity of the spine. It may occur at any time throughout growth and development and is typically detected through x-ray imaging. Although effective at visualizing a curve, x-ray imaging is costly and may expose children to potentially harmful ionizing radiation. This is a 30 patient study to evaluate the reliability of ultrasound, an imaging technique without radiation, to effectively measure scoliosis deformities compared to the gold-standard of x-ray.
Detailed description
All patients who present to Children's National Medical Center for initial evaluation of idiopathic or juvenile scoliosis will be approached.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm unblinded group of patients will receive ultrasound imaging of spine.
| Arm | Type | Receives |
|---|---|---|
| Device Arm | Other | Device: UltrasoundThis is a single arm study comparing an ultrasound with the industry standard of x-ray to detect and monitor scoliosis curvature. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- All patients ages 7-17 years who present to Dr. Matthew Oetgen in the Department of Orthopaedic Surgery \& Sports Medicine for clinical evaluation of scoliosis,
- Scoliosis curve type to include adolescent idiopathic (AIS) or juvenile, and
- Have x-rays taken as part of clinical evaluation
Key exclusion criteria (3 listed)
- Not willing or able to provide consent, or
- Had x-rays taken at an outside facility, or
- Any underlying neuromuscular condition or syndrome and congenital deformities
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 |
|---|---|---|
| UltrasoundAn industry standard ultrasound will be fitted with a self-tracking probe to track along the spine. The ultrasound will be performed three (3) times along the spine at initial consultation for scoliosis. | Device | Device Arm |
Primary outcome
Imaging
Time frame: 3 years
Ability of the ultrasound to produce a radiographic measurement (e.g. coronal spinal curvature, coronal spinal rotation) within the variability of the gold standard of x-ray
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
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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.
Matthew Oetgen, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Scoliosis Idiopathic and Scoliosis; Juvenile, run by Children's National Research Institute 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: status not confirmed, as of the sponsor's last update on 1 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonise Handy-Richards, AAS (202-476-4652, jhandy@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging (time frame: 3 years). 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 1 Feb 2023.