Study of 3D Scanning for Adolescent Scoliosis

NSite Medical

Status: Enrolling

Conditions: Scoliosis

Treatments: Diagnostic Test: 3D topographical scan

Study type: Observational

Funder types: Industry

Identifiers

NCT06035952

54101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

70 participants in 1 patient group

Intervention

Description:

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.

Treatment:

Diagnostic Test: 3D topographical scan