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

NCT06777992 | Not Yet Recruiting DMC

• 1 other identifier: St. Justine's Hospital
• Study Type: observational
• Target: 142
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Idiopathic scoliosis; Screening; Spine deformity; Progression; Non-invasive 3D scans; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Cobb angle

  The primary outcomes will be clinical progression including: Cobb angle of the main curve at 1 and 2 years of follow up, progression of Cobb angle of more than 5 degrees, whether the main curve reaches 45 degrees during follow-up or whether the patient is referred to surgery.

  1 and 2 years

Secondary Outcomes (1)

• Performance of the software

  All the time

Study Arms (2)

Control arm

Standard care will be provided to the control arm group. This includes standard 4 to 6-month consultatiosn with the orthopedic surgeons, follow-up standard x-ray (lateral and posterioanterior) examinations, measures of the angle of trunk rotation and Cobb angles, topographic scans performed by the study coordinator using the Momentum Health TM application, at each clincal visits.

Intervention arm

In addition to the standard care, patients randomized to the Intervention arm of the trial will perform Momentum SpineTM assessment from home at 2-month intervals during the 24-month study follow-up. 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.

Other: Home topographic scans

Interventions

Home topographic scans OTHER

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.

Intervention arm

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children with idiopathic scoliosis diagnosis.

You may qualify if:

• Children aged between 8 and 14 with a confirmed radiographic diagnosis of Idiopathic Scoliosis who have not undergone spinal nor thoracic surgery.

You may not qualify if:

• Patients who may be pregnant. Patients with the existence of a second deformity, or any other neuromuscular condition.

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Mitacs: collaborator
• Ministère de l'économie, de l'innovation et de l'énergie du Québec: collaborator
• Momentum Health Inc.: collaborator
• Université de Sherbrooke: collaborator
• Université Clermont-Auvergne, France: collaborator

Related Publications (3)

• Girdler S, Cho B, Mikhail CM, Cheung ZB, Maza N, Kang-Wook Cho S. Emerging Techniques in Diagnostic Imaging for Idiopathic Scoliosis in Children and Adolescents: A Review of the Literature. World Neurosurg. 2020 Apr;136:128-135. doi: 10.1016/j.wneu.2020.01.043. Epub 2020 Jan 16.

  PMID: 31954891 BACKGROUND

• Elwyn G, Edwards A, Wensing M, Grol R. Shared Decision Making Measurement using the OPTION instrument. 2005. Accessible from

  BACKGROUND

• Weinstein SL, Dolan LA, Cheng JC, Danielsson A, Morcuende JA. Adolescent idiopathic scoliosis. Lancet. 2008 May 3;371(9623):1527-37. doi: 10.1016/S0140-6736(08)60658-3.

  PMID: 18456103 BACKGROUND

MeSH Terms

Conditions

Disease Progression

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marie Beauséjour, PhD

CONTACT

+1 514 345-4931; marie.beausejour@usherbrooke.ca

Marjolaine Roy-Beaudry, MSc

CONTACT

+1 514 345-4931; marjolaine.roy-beaudry.hsj@ssss.gouv.qc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Researcher

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 16, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share