Detecting and Monitoring Scoliosis Without Radiography: Standard Radiographic Monitoring Program Versus Self-Screening with Momentum SpineTM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Momentum Application.
- Who it may be relevant to
- Registry conditions: Adolescent Idiopathic Scoliosis. Basic parameters: 8 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Momentum Application
A mobile application to scan and predict spinal curvature. The application monitors curvature and track changes over time.
Primary outcome measures
- Accuracy of Scoliosis Progression [Time frame: Immediately from enrollment and monthly through study completion]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06825611 · CHLA-24-00371