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| Name | Class |
|---|---|
| Momentum Health Inc. | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Momentum Application | Experimental | Patients diagnosed with scoliosis between 8-18 years of age |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Momentum Application | Device | A mobile application to scan and predict spinal curvature. The application monitors curvature and track changes over time. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately from enrollment and monthly through study completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiffany Phan, BA | Contact | 3234612142 | tphan@chla.usc.edu | |
| Lindsay M Andras, MD | Contact | 323-361-2148 | landras@chla.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lindsay M Andras, MD | Children's Hospital Los Angeles | Principal Investigator |
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| 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. | 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. | 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. | 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). | Immediately from enrollment and monthly through study completion |