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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorChildren's Hospital Los Angeles

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Momentum Application

Treatment groups

100 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Children's Hospital Los Angeles

Lead sponsor

Momentum Health Inc.

Collaborator