Study of 3D Scanning for Adolescent Scoliosis
Prospective Validation of 3D Body Surface Modeling for Patient Monitoring in Adolescent Idiopathic Scoliosis
1 other identifier
observational
70
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2023
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 7, 2023
CompletedFirst Submitted
Initial submission to the registry
August 31, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2023
CompletedSeptember 13, 2023
September 1, 2023
2 months
August 31, 2023
September 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Repeatability of 3D scan analysis
Within 48 hours
Study Arms (1)
Intervention
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.
Interventions
Subjects will undergo a quick, radiation-free, no contact 3D scan using a smartphone.
Eligibility Criteria
The study population will include children and adolescent patients 10 to 18 years old who present to a pediatric orthopedic clinic for scoliosis evaluation. This age range was chosen as it is the age range in which Adolescent Idiopathic Scoliosis commonly appears, and the device is intended for screening for this condition.
You may qualify if:
- Ages 10 and 18 years old
You may not qualify if:
- Scoliosis caused by another condition (e.g., secondary scoliosis)
- Parents/guardians unable to consent
- English is not the primary language (to avoid miscommunication)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NSite Medicallead
Study Sites (2)
Stanford University School of Medicine
Palo Alto, California, 94063, United States
Duke University
Durham, North Carolina, 27708, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kali Tileston, MD
Stanford University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2023
First Posted
September 13, 2023
Study Start
August 7, 2023
Primary Completion
October 15, 2023
Study Completion
December 15, 2023
Last Updated
September 13, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share