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

NCT ID: NCT06825611

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2027-08-15

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Momentum Application

Patients diagnosed with scoliosis between 8-18 years of age

Group Type: EXPERIMENTAL

Momentum Application

Intervention Type: DEVICE

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

Interventions

Momentum Application

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Momentum Health Inc.

INDUSTRY

Sponsor Role: collaborator

Children's Hospital Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Lindsay Andras

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lindsay M Andras, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Central Contacts

Tiffany Phan, BA

Role: CONTACT

tphan@chla.usc.edu

3234612142

Lindsay M Andras, MD

Role: CONTACT

landras@chla.usc.edu

323-361-2148

Other Identifiers

CHLA-24-00371

Identifier Type: -

Identifier Source: org_study_id