Implementation of Momentum SpineTM: a New 3D Imaging Software for Idiopathic Scoliosis

Summary

Brief Summary

The goal of this clinical trial is to evaluate the implementation of Momentum Spine™, a new 3D imaging software designed to improve the monitoring and management of idiopathic scoliosis in children aged 8-14 years. Idiopathic scoliosis affects 1-3% of the pediatric population and is currently monitored through hospital visits with radiographic imaging every 4-6 months, which exposes patients to cumulative radiation over time. This study explores whether Momentum Spine™ can provide a safer, more accessible alternative by enabling at-home monitoring using clinical photographs taken on smartphones.

The primary questions this study seeks to answer are:

Can Momentum Spine™ accurately predict scoliosis progression, including Cobb angle changes, compared to standard radiographic assessments? Can the use of Momentum Spine™ reduce the number of X-rays required and improve the timing of clinical follow-ups? Does the use of Momentum Spine™ affect patient satisfaction, healthcare utilization, and overall quality of life? This study is a prospective, two-arm randomized controlled trial conducted at CHU Sainte-Justine. Participants will be divided into two groups: the control group will receive standard care, which involves regular clinical visits and radiographic evaluations; the intervention group will use Momentum Spine™ at home, alongside standard care.

Intervention Details

Participants in the intervention group will:

Use the Momentum Spine™ application to capture 3D images of their torso at home every two months. These images will be processed by Momentum Spine™ algorithms to assess curve progression.

Participants will receive notifications and guidance on performing scans at home, supported by the study team to ensure accuracy.

The primary outcomes include clinical measures such as changes in Cobb angle at 1 and 2 years, curve progression of more than 5 degrees, whether the main curve reaches 45 degrees, and the need for surgical referral. Secondary outcomes focus on the accuracy, sensitivity, and specificity of Momentum Spine™, as well as patient-reported measures such as health-related quality of life and satisfaction with care, users' acceptability of the software, healthcare services utilization and pathway costs.

This study also aims to address key challenges in scoliosis care, including reducing radiation exposure, improving follow-up timing to align with growth spurts, and providing equitable access to care for families who may live far from specialty clinics. By validating the performance of Momentum Spine™, this trial has the potential to transform scoliosis management, ensuring safer and more effective care pathways.

Conditions

• Spine Deformity
• Idiopathic Scoliosis

Interventions

OTHER

Home topographic scans

Patients randomized to the Intervention arm of the trial will additionally use Momentum SpineTM assessment from home at 2-month intervals. If a progression is detected using Momentum SpineTM the participant will be promptly invited to acquire a second set of scans for confirmation. In case of confirmation of the progression using the images from the repeated scans, the scan results will be sent to their local orthopedic surgeon.

Sponsors & Collaborators

• Mitacs

  collaborator INDUSTRY

• Ministère de l'économie, de l'innovation et de l'énergie du Québec

  collaborator UNKNOWN

• Momentum Health Inc.

  collaborator INDUSTRY

• Université de Sherbrooke

  collaborator OTHER

• Université Clermont-Auvergne, France

  collaborator UNKNOWN

• St. Justine's Hospital

  lead OTHER

Eligibility

Min Age

8 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-03-31

Primary Completion

2027-12-31

Completion

2028-12-31