Spine DeformityNCT06777992
Implementation of Momentum SpineTM: a New 3D Imaging Software for Idiopathic Scoliosis
An observational study of Spine Deformity and Idiopathic Scoliosis, run by St. Justine's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Spine Deformity, Idiopathic Scoliosis
- What is being tested?
- Home topographic scans
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with idiopathic scoliosis diagnosis.
Who may be able to join
- Children aged between 8 and 14 with a confirmed radiographic diagnosis of Idiopathic Scoliosis who have not undergone spinal nor thoracic surgery.
Who cannot join
- Patients who may be pregnant. Patients with the existence of a second deformity, or any other neuromuscular condition.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Marjolaine Roy-Beaudry, MSc contact
About this study
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.
Read more
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.
Read the detailed description
This study evaluates the implementation of Momentum Spine™, a novel 3D imaging technology that allows at-home monitoring for patients with idiopathic scoliosis. The objective is to determine whether Momentum Spine™ is as effective as standard radiographic assessments in tracking scoliosis progression while reducing radiation exposure and improving the timing of follow-ups.
Study Rationale \& Background:
Idiopathic scoliosis affects approximately 1-3% of the pediatric population and is typically monitored through radiographic imaging every 4-6 months. However, this conventional approach exposes children to significant cumulative radiation over time and is associated with missed opportunities for timely intervention, especially during growth spurts. Momentum Spine™ uses clinical photographs taken on smartphones to generate 3D topographic models of the torso. These models allow for the calculation of the Cobb angle and the detection of curve progression, without requiring frequent radiographs.
Study Design:
This study is a two-arm, randomized controlled trial conducted at CHU Sainte-Justine. Participants will be randomized into two groups:
Control Group: Participants will receive standard care, including radiographic assessments and clinical visits as per current practice.
Intervention Group: Participants will use the Momentum Spine™ 3D imaging software in combination with standard care. They will be asked to perform at-home scans every two months using the Momentum Spine™ application. These scans will be reviewed to track scoliosis progression and compare them to standard clinical evaluations.
Study Objectives:
Primary Objective: Compare the clinical outcomes between participants receiving standard care versus those using Momentum Spine™ in addition to standard care. Key outcomes include changes in Cobb angle and curve progression over a 24-month follow-up.
Secondary Objective: Assess the accuracy of Momentum Spine™'s algorithm compared to radiographic assessments, the proportion of avoidable X-rays, and patient satisfaction during the monitoring period.
Study Procedures:
Participants in the intervention group will receive training on using Momentum Spine™ to capture 3D topographic scans at home every two months. Scans will be submitted through secure servers to Momentum Health for automated analysis. If scans indicate progression of more than 6 degrees in the Cobb angle, participants will be contacted by the research coordinator for confirmation. Results will be shared with the treating orthopedic surgeons to determine whether advanced intervention is required.
The standard of care for both groups will involve clinical visits at regular intervals (every 4-6 months) to assess scoliosis progression and standard clinical management options, including observation, bracing, physiotherapy, or surgical referral when necessary.
Participant Safety:
All participants will follow the standard scoliosis care protocols as recommended by their healthcare providers. Topographic scans and Momentum Spine™ assessments are intended to complement standard care by providing earlier detection of scoliosis progression while minimizing unnecessary radiation exposure. Data privacy and confidentiality are rigorously maintained by encrypting images and anonymizing all scans analyzed by Momentum Health.
Expected Outcomes:
The study will assess whether Momentum Spine™ can accurately predict the Cobb angle of the main curve and be used to detect significant scoliosis progression. It will also explore the number of radiogrpahs that could have been avoided in case of adequate prediction. Additionally, the study will evaluate patient-reported experiences related to satisfaction with care, quality of life, and overall health system use.
This study could lead to a novel, non-invasive approach to scoliosis monitoring and care, with the potential to improve patient outcomes while reducing the risks associated with cumulative radiation exposure from standard imaging methods.
- Conditions
- Spine Deformity, Idiopathic Scoliosis
- Being tested
- Home topographic scans
- Keywords
- Idiopathic scoliosis, Screening, Spine deformity, Progression, Non-invasive 3D scans, Pediatrics
- Medical subject headings
- Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home topographic scansOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Home topographic scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 and 2 years
Secondary outcomes (1)
Performance of the software
Secondary outcomes will relate to the performance of the software: accuracy, margin of error, sensitivity, specificity, AUC, overall agreement with radiographs; as well as proportion of accelerated clinical visits and proportion of avoidable x-rays. Additional outcomes will be captured assessing the patient and system related outcomes including: health-related quality of life and satisfaction with care, users' acceptability of the software, healthcare service utilisation and costs of pathways
Measured: All the time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study startMar 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spine DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mitacs, Ministère de l'économie, de l'innovation et de l'énergie du Québec, Momentum Health Inc., Université de Sherbrooke, Université d'Auvergne
- Responsible party
- Principal investigator, Marie Beausejour, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777992
- Sponsor's protocol ID
- St. Justine's Hospital
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31954891Elwyn G, Edwards A, Wensing M, Grol R. Shared Decision Making Measurement using the OPTION instrument. 2005. Accessible from
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.
PubMed 18456103
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Momentum SpineTM: a New 3D Imaging Software for Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06777992
- Acronym / sponsor ID
- St. Justine's Hospital
- Conditions
- Spine Deformity, Idiopathic Scoliosis
- Keywords
- Idiopathic scoliosis, Screening, Spine deformity, Progression, Non-invasive 3D scans, Pediatrics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Mitacs, Ministère de l'économie, de l'innovation et de l'énergie du Québec, Momentum Health Inc., Université de Sherbrooke, Université d'Auvergne
- Study start
- Mar 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study evaluates the implementation of Momentum Spine™, a novel 3D imaging technology that allows at-home monitoring for patients with idiopathic scoliosis. The objective is to determine whether Momentum Spine™ is as effective as standard radiographic assessments in tracking scoliosis progression while reducing radiation exposure and improving the timing of follow-ups.
Study Rationale \& Background:
Idiopathic scoliosis affects approximately 1-3% of the pediatric population and is typically monitored through radiographic imaging every 4-6 months. However, this conventional approach exposes children to significant cumulative radiation over time and is associated with missed opportunities for timely intervention, especially during growth spurts. Momentum Spine™ uses clinical photographs taken on smartphones to generate 3D topographic models of the torso. These models allow for the calculation of the Cobb angle and the detection of curve progression, without requiring frequent radiographs.
Study Design:
This study is a two-arm, randomized controlled trial conducted at CHU Sainte-Justine. Participants will be randomized into two groups:
Control Group: Participants will receive standard care, including radiographic assessments and clinical visits as per current practice.
Intervention Group: Participants will use the Momentum Spine™ 3D imaging software in combination with standard care. They will be asked to perform at-home scans every two months using the Momentum Spine™ application. These scans will be reviewed to track scoliosis progression and compare them to standard clinical evaluations.
Study Objectives:
Primary Objective: Compare the clinical outcomes between participants receiving standard care versus those using Momentum Spine™ in addition to standard care. Key outcomes include changes in Cobb angle and curve progression over a 24-month follow-up.
Secondary Objective: Assess the accuracy of Momentum Spine™'s algorithm compared to radiographic assessments, the proportion of avoidable X-rays, and patient satisfaction during the monitoring period.
Study Procedures:
Participants in the intervention group will receive training on using Momentum Spine™ to capture 3D topographic scans at home every two months. Scans will be submitted through secure servers to Momentum Health for automated analysis. If scans indicate progression of more than 6 degrees in the Cobb angle, participants will be contacted by the research coordinator for confirmation. Results will be shared with the treating orthopedic surgeons to determine whether advanced intervention is required.
The standard of care for both groups will involve clinical visits at regular intervals (every 4-6 months) to assess scoliosis progression and standard clinical management options, including observation, bracing, physiotherapy, or surgical referral when necessary.
Participant Safety:
All participants will follow the standard scoliosis care protocols as recommended by their healthcare providers. Topographic scans and Momentum Spine™ assessments are intended to complement standard care by providing earlier detection of scoliosis progression while minimizing unnecessary radiation exposure. Data privacy and confidentiality are rigorously maintained by encrypting images and anonymizing all scans analyzed by Momentum Health.
Expected Outcomes:
The study will assess whether Momentum Spine™ can accurately predict the Cobb angle of the main curve and be used to detect significant scoliosis progression. It will also explore the number of radiogrpahs that could have been avoided in case of adequate prediction. Additionally, the study will evaluate patient-reported experiences related to satisfaction with care, quality of life, and overall health system use.
This study could lead to a novel, non-invasive approach to scoliosis monitoring and care, with the potential to improve patient outcomes while reducing the risks associated with cumulative radiation exposure from standard imaging methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Home topographic scansIn 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. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with idiopathic scoliosis diagnosis.
Key inclusion criteria (1 listed)
- Children aged between 8 and 14 with a confirmed radiographic diagnosis of Idiopathic Scoliosis who have not undergone spinal nor thoracic surgery.
Key exclusion criteria (1 listed)
- Patients who may be pregnant. Patients with the existence of a second deformity, or any other neuromuscular condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home topographic scansPatients 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. | Other | Intervention arm |
Primary outcome
Cobb angle
Time frame: 1 and 2 years
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 secondary outcome
Performance of the software
Time frame: All the time
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Background: PubMed 31954891Girdler 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.
- BackgroundElwyn G, Edwards A, Wensing M, Grol R. Shared Decision Making Measurement using the OPTION instrument. 2005. Accessible from
- Background: PubMed 18456103Weinstein 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marjolaine Roy-Beaudry, MSc contact
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Deformity and Idiopathic Scoliosis, run by St. Justine's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Beauséjour, PhD (+1 514 345-4931 ext. 4796, marie.beausejour@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobb angle (time frame: 1 and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06777992, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.