An interventional study of Momentum Application in Adolescent Idiopathic Scoliosis, sponsored by Children's Hospital Los Angeles. Not yet recruiting. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-03-04.
Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Supportive care
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]:
Participants will:
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's planned enrollment of 100 is above the median of 44 across 344 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →Children's Hospital Los Angeles is the lead sponsor of 150 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients diagnosed with scoliosis between 8-18 years of age
Device: Momentum Application
A mobile application to scan and predict spinal curvature. The application monitors curvature and track changes over time.
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.
Time frame: Immediately from enrollment and monthly through study completion
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Immediately from enrollment and monthly through study completion
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Children's Hospital Los Angeles