Prospective Validation of 3D Body Surface Modeling for Patient Monitoring in Adolescent Idiopathic Scoliosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Stanford University
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- Assess the reproducibility of NSite device
Study Overview
Brief Summary
This is a single center, prospective, non-randomized reproducibility study of the NSite device in patients undergoing evaluation for scoliosis. The NSite device is a pre-market, investigational device. The study will enroll 13 eligible patients, who will be scanned using the NSite device by 3 separate users in order to assess if the device generates similar results across users. This data will be used to support 510(k) submission.
Detailed Description
The primary objective of this study is to validate the reproducibility of device output in multiple users in a clinical setting. Device output will be predicted probability of major curve magnitude (i.e., Cobb angle) greater than or equal to 20 degrees with 95% confidence interval. We will test whether users obtain similar device output when measuring the same participant (at least 2 scans required for analysis). After excluding bad quality scans, the measurements obtained by these different users (at least 2 users after excluding bad scans) on each study participant will then be compared to determine if they are congruent (having overlapping confidence intervals) or different. The percentage of participants for which users generated congruent predicted probabilities will be reported.
The NSite Scoliosis Assessment App is intended as a clinical decision support tool and requires interpretation by the healthcare professional. It is intended for use for children and adolescent patients 10 to 18 years old. It is for use by prescription only. The NSite Scoliosis Assessment App provides a calculated Asymmetry Index for patients with or at risk for scoliosis, which will yield an output of percentage risk of major curve magnitude (i.e., Cobb angle) greater than 20 degrees, with 95% confidence intervals.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 10 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ages 10 and 18 years old
- •Referred for evaluation of or diagnosed of adolescent idiopathic scoliosis
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)
Outcomes
Primary Outcomes
Assess the reproducibility of NSite device
Time Frame: Anticipated to take about one month in order to recruit, enroll, and scan 13 patients.
Percentage of scan outputs reproducible. The percentage of scan sets (3 scans for each participant) that have reproducible predicted probabilities for major curve magnitude ≥ 20 degrees. A reproducible output will be defined as a scan set in which all scans have overlapping 95% confidence intervals for the predicted probability of major curve magnitude ≥ 20 degrees.
Secondary Outcomes
- User Feedback(Anticipated to take about one month in order to recruit, enroll, and scan 13 patients.)
Investigators
John Vorhies
Clinical Associate Professor, Orthopaedic Surgery
Stanford University