Study of 3D Scanning for Adolescent Scoliosis

Study Overview
=================
Brief Summary
-----------------
The investigators aim to validate three-dimensional topographical scanning technology as a tool for evaluation of scoliosis. Through the incorporation of 3D topographical technology in the measurement of deformity, the investigators hope to validate a novel approach to quantify deformity progression and provide an accessible alternative to traditional radiographic workup.

Detailed Description
-----------------
The study design will be prospective observational. Patients 10 to 18 years old being evaluated or followed for scoliosis will be included. Those unable to complete the consent and assent processes will not be enrolled. Members of the research team will review the clinic schedule through EPIC each week to identify eligible patients. Member of the patient's care team, such as the physician, will introduce the study to the patient. If the patient and the patient's caregivers are interested in learning more and/or participating, a member of the research team will provide study-related information and obtain informed consent via written or electronic consent, assent, and, if necessary, short form consent. If a patient consents to participate, members of the research team will conduct the 3D topographical scan in a private room in the clinic. This involves 360 degree scans using a smartphone camera. Participants will also receive any standard of care x-rays during the visit. The investigators will then analyze the ability of the 3D smartphone scan to estimate the Cobb Angle measured on the X-ray, to infer the magnitude of the scoliosis deformity.

Official Title
-----------------
Prospective Validation of 3D Body Surface Modeling for Patient Monitoring in Adolescent Idiopathic Scoliosis

Conditions
-----------------
Scoliosis

Intervention / Treatment
-----------------
* Diagnostic Test: 3D topographical scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 10 and 18 years old Exclusion Criteria: Scoliosis caused by another condition (e.g., secondary scoliosis) Parents/guardians unable to consent English is not the primary language (to avoid miscommunication)

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention<br>This study will have one cohort. This group of patients will undergo 3D scanning with a smartphone, and will also have standard of care diagnostics, such as an X-ray. | Diagnostic Test: 3D topographical scan<br>* Subjects will undergo a quick, radiation-free, no contact 3D scan using a smartphone.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of scanning device to predict clinically significant Cobb Angle | The primary study endpoint, or primary outcome, is whether the 3D scan's predicted probability of clinically significant Cobb angle correlates with the ground truth radiograph obtained Cobb angle at the defined rate. The percentage (%) of patient scans with predicted probabilities that correlate with ground truth results will be reported. | Through study completion, an average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatability of 3D scan analysis | After the 3D scan is obtained, several personnel will align the scan relative to grid coordinates, and place a region of interest on the back of the scan. Measurements will be performed which will generate an asymmetry value, which is used to assess Cobb Angle correlation. The investigators will determine the repeatability of this manual scan assessment process. | Within 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
scoliosis, topographical scanning