An observational study in Scoliosis, sponsored by NSite Medical. Recruiting at 2 sites in United States. Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by NSite Medical · Observational
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.
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.
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's planned enrollment of 70 is below the median of 89 across 233 observational studies indexed under Scoliosis.
Browse Scoliosis studies →This is the only study on the registry with NSite Medical as lead sponsor.
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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.
Exclusion Criteria:
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
Subjects will undergo a quick, radiation-free, no contact 3D scan using a smartphone.
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.
Time frame: Through study completion, an average of 3 months
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.
Time frame: Within 48 hours
Plan to share: No
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