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Detecting and Monitoring Scoliosis Without Radiography: Standard Radiographic Monitoring Program Versus Self-Screening with Momentum SpineTM

NCT06825611 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-03-04

No results posted yet for this study

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. 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.

Conditions

  • Adolescent Idiopathic Scoliosis

Interventions

DEVICE

Momentum Application

A mobile application to scan and predict spinal curvature. The application monitors curvature and track changes over time.

Sponsors & Collaborators

Principal Investigators

  • Lindsay M Andras, MD · Children's Hospital Los Angeles

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-15
Primary Completion
2027-08-15
Completion
2027-08-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06825611 on ClinicalTrials.gov