Study of 3D Scanning for Adolescent Scoliosis

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035952
• Other study ID #: 54101
• Status: Recruiting
• Start date: August 7, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: September 2023
• Source: NSite Medical
• Contact: Michael J. Gardner, MD
• Phone: 9175846909
• Email: mike[@]nsitemedical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 15, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Scoliosis

Intervention

Diagnostic Test:
• 3D topographical scan
Subjects will undergo a quick, radiation-free, no contact 3D scan using a smartphone.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	Stanford University School of Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
NSite Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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