Adolescent Idiopathic ScoliosisNCT06825611
Detecting and Monitoring Scoliosis Without Radiography: Standard Radiographic Monitoring Program Versus Self-Screening With Momentum SpineTM
A study testing Momentum Application in people with Adolescent Idiopathic Scoliosis, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
The goal of this clinical trial is for the Momentum SpineTM application to accurately detect scoliosis progression, including accuracy, margin of error, sensitivity, specificity, AUC, and overall agreement with radiographs in 8-18 year olds with adolescent idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Momentum Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2025to 15 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children between the ages of 8-18 years of age
- Confirmed radiographic diagnosis of adolescent idiopathic scoliosis
- No history of spinal/ chest surgery.
- Participants who have had spine x-rays ±1 week as baseline visit at CHLA will be included in the study.
- Participants who have identifiable markings such as tattoos or birthmarks can be included in the study, though their markings will be covered with tape.
Who cannot join
- Participants who have had x-rays in a brace will not be included.
- Participants who have had an x-ray from another institution will not be included in the study. X-rays from out of community are typically done with a different and lower quality machine then the one at our institution. Additionally, we do not have consent from outside institutions to use their x-rays for research purposes.
- Participants with a confirmed pregnancy will not be included. Pregnancy status will be self-reported by participants.
- Participants with the existence of a second deformity which may affect topographic assessment will be excluded (e.g. Limb length discrepancy greater than 2cm).
- Families who do not speak English and Spanish will be unable to participate as the application is only available in English and Spanish at this time.
- Families who do not have access to their own compatible personal smart phone device will be unable to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Lindsay M Andras, MD, 323-361-2142, orthoresearch@chla.usc.edu
About this study
The goal of this clinical trial is for the Momentum SpineTM application to accurately detect scoliosis progression, including accuracy, margin of error, sensitivity, specificity, AUC, and overall agreement with radiographs in 8-18 year olds with adolescent idiopathic scoliosis. The main question it aims to answer [is/are]:
- Based on previous data it is hypothesize that Momentum SpineTM imaging software will be able to accurately detect scoliosis progression (>= 7 degrees), including accuracy, margin of error, sensitivity, specificity, AUC, and overall agreement with radiographs.
- Based on the above hypothesis that Momentum SpineTM is able to accurately detect scoliosis and curve progression (>= 7 degrees).
- It is hypothesized there will be indications for accelerated clinical visits based on at home detection of progression, and that these visits will be accurate and necessary.
- It is hypothesized that there will be a proportion of standard care visits that are deemed unnecessary, and that the application is able to accurately predict these visits.
Read more
Participants will:
- Use Momentum SpineTM assessment from home to perform body scans at 1-month intervals on personal device and during the clinical visit.
- Received monthly scans that will be evaluated by the provider using the application.
- Receive additional scans as warranted.
- Complete net promoter score (NPS) within the application following completion of a body scan.
- Complete a patient satisfaction survey following 6 months of application usage.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Momentum Application
- Keywords
- spinal curve monitoring, Scoliosis mobile application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Momentum ApplicationDevice
A mobile application to scan and predict spinal curvature. The application monitors curvature and track changes over time.
| Study group | Role | What they receive |
|---|---|---|
| Momentum Application | Experimental | Patients diagnosed with scoliosis between 8-18 years of age Receives: Device: Momentum Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Scoliosis Progression
Progression will be defined as a change of greater than or equal to 7 degrees. The progression between the application will be compared to the radiographs done manually, with evaluation of the margin of error, sensitivity, specificity, AUC, and overall agreement with the radiographs.
Measured: Immediately from enrollment and monthly through study completion
Secondary outcomes (5)
Proportion of follow-up visits that were correctly accelerated
Accelerated visits are defined as medical appointments less than 6 months apart (sooner than routine follow-up) suggested by the Momentum Spine mobile application. When Momentum Spine detects progression on 3D models obtained at home, it suggests the clinical team see that patient sooner than the planned semi-annual visit in order to implement treatments earlier (bracing, change in brace, etc.). This endpoint will calculate the percentage of accelerated visits suggested by Momentum Spine where scoliosis progression was present as well as where a change in treatment was required.
Measured: Immediately from enrollment through study completion, at an average of 2 years
Necessity of visit
Coronal curve magnitude between site-specific X-ray measurements and coronal curve magnitude predictions output by Momentum Spine will be compared . The cutoff to determine whether the predicted coronal curve magnitude will be a difference of +/- 7 degrees when compared to the average of the readings from x-rays.
Progression noted via Momentum Spine and on radiographs will be compared.
Necessary visit = Radiographic Progression >7 degrees Unnecessary visit = Radiographic Progression <7 degrees
Percentage agreement between Radiographic and MS progression values, with a cutoff point of 7 degrees, will be assessed.
Measured: Immediately from enrollment and monthly through study completion
Proportion of avoidable x-rays using Momentum Spine
An avoidable x-ray is defined as the percentage of radiographs obtained as part of routine semi-annual follow-up that show an absence of scoliosis progression where Momentum Spine was in agreement. This metric demonstrates that Momentum Spine is an accurate tool for determining when spinal radiographs are necessary.
Measured: Immediately from enrollment and monthly through study completion
Patient Satisfaction Survey
The patient satisfaction survey consists of 6 open-ended questions to understand what the experience has been for the individual using the application.
Measured: Only at the 6 month visit
Net Promoter Score
The Net Promoter Score (NPS) is measured by collecting patient/parent ratings on a 0-10 scale in response to questions on how likely they would use the app. The data is collected via a survey embedded within the product. The score uses a scale between a minimum value of 0 (worst) to a maximum value of 5(best).
Measured: Immediately from enrollment and monthly through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start20 Apr 2025
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Momentum Health Inc.
- Responsible party
- Principal investigator, Lindsay Andras, Children's Hospital Los Angeles
- Investigators
- Lindsay M Andras, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825611
- Sponsor's protocol ID
- CHLA-24-00371
- Status last verified
- Oct 2026
- First submitted
- 10 Feb 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting and Monitoring Scoliosis Without Radiography: Standard Radiographic Monitoring Program Versus Self-Screening With Momentum SpineTM
- ClinicalTrials.gov ID
- NCT06825611
- Acronym / sponsor ID
- CHLA-24-00371
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- spinal curve monitoring, Scoliosis mobile application
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- Momentum Health Inc.
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 13 Feb 2025 (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 goal of this clinical trial is for the Momentum SpineTM application to accurately detect scoliosis progression, including accuracy, margin of error, sensitivity, specificity, AUC, and overall agreement with radiographs in 8-18 year olds with adolescent idiopathic scoliosis. The main question it aims to answer [is/are]:
- Based on previous data it is hypothesize that Momentum SpineTM imaging software will be able to accurately detect scoliosis progression (>= 7 degrees), including accuracy, margin of error, sensitivity, specificity, AUC, and overall agreement with radiographs.
- Based on the above hypothesis that Momentum SpineTM is able to accurately detect scoliosis and curve progression (>= 7 degrees).
- It is hypothesized there will be indications for accelerated clinical visits based on at home detection of progression, and that these visits will be accurate and necessary.
- It is hypothesized that there will be a proportion of standard care visits that are deemed unnecessary, and that the application is able to accurately predict these visits.
Participants will:
- Use Momentum SpineTM assessment from home to perform body scans at 1-month intervals on personal device and during the clinical visit.
- Received monthly scans that will be evaluated by the provider using the application.
- Receive additional scans as warranted.
- Complete net promoter score (NPS) within the application following completion of a body scan.
- Complete a patient satisfaction survey following 6 months of application usage.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Momentum Application | Experimental | Device: Momentum ApplicationPatients diagnosed with scoliosis between 8-18 years of age |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Children between the ages of 8-18 years of age
- Confirmed radiographic diagnosis of adolescent idiopathic scoliosis
- No history of spinal/ chest surgery.
- Participants who have had spine x-rays ±1 week as baseline visit at CHLA will be included in the study.
- Participants who have identifiable markings such as tattoos or birthmarks can be included in the study, though their markings will be covered with tape.
Key exclusion criteria (6 listed)
- Participants who have had x-rays in a brace will not be included.
- Participants who have had an x-ray from another institution will not be included in the study. X-rays from out of community are typically done with a different and lower quality machine then the one at our institution. Additionally, we do not have consent from outside institutions to use their x-rays for research purposes.
- Participants with a confirmed pregnancy will not be included. Pregnancy status will be self-reported by participants.
- Participants with the existence of a second deformity which may affect topographic assessment will be excluded (e.g. Limb length discrepancy greater than 2cm).
- Families who do not speak English and Spanish will be unable to participate as the application is only available in English and Spanish at this time.
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 |
|---|---|---|
| Momentum ApplicationA mobile application to scan and predict spinal curvature. The application monitors curvature and track changes over time. | Device | Momentum Application |
Primary outcome
Accuracy of Scoliosis Progression
Time frame: Immediately from enrollment and monthly through study completion
Progression will be defined as a change of greater than or equal to 7 degrees. The progression between the application will be compared to the radiographs done manually, with evaluation of the margin of error, sensitivity, specificity, AUC, and overall agreement with the radiographs.
5 secondary outcomes
Proportion of follow-up visits that were correctly accelerated
Time frame: Immediately from enrollment through study completion, at an average of 2 years
Necessity of visit
Time frame: Immediately from enrollment and monthly through study completion
Proportion of avoidable x-rays using Momentum Spine
Time frame: Immediately from enrollment and monthly through study completion
Patient Satisfaction Survey
Time frame: Only at the 6 month visit
Net Promoter Score
Time frame: Immediately from enrollment and monthly through study completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Lindsay M Andras, MD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Momentum Application in people with Adolescent Idiopathic Scoliosis, run by Children's Hospital Los Angeles 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiffany Phan, BA (3234612142, tphan@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Scoliosis Progression (time frame: Immediately from enrollment and monthly through study completion). 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 26 Oct 2026.