N/A
N=1,903
Validation of an Artificial Intelligence-based Algorithm for Skeletal Age Assessment
Bone Age
Bottom Line
View on ClinicalTrials.gov: NCT03530098 ↗Enrolled (actual)
1,903
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Paired Difference of Skeletal Age Estimate — 5.95; 5.36 months — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BoneAgeModel (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Paired Difference of Skeletal Age Estimate |
5.95; 5.36 | 0.04 sig |
| SECONDARY Time for Diagnosis |
142; 102 | 0.001 sig |
Summary
The purpose of this study is to understand the effects of using an Artificial Intelligence algorithm for skeletal age estimation as a computer-aided diagnosis (CADx) system. In this prospective real-time study, the investigators will send de-identified hand radiographs to the Artificial Intelligence algorithm and surface the output of this algorithm to the radiologist, who will incorporate this information with their normal workflows to make an estimation of the bone age. All radiologists involved in the study will be trained to recognize the surfaced prediction to be the output of the Artificial Intelligence algorithm. The radiologists' diagnosis will be final and considered independent to the output of the algorithm.
Eligibility Criteria
Exams that meet the following inclusion criteria will be included: (1) exams read by radiologists who interpret pediatric skeletal age exams and verbally consent to participate (2) exams that contain a procedure code or study description indicative of a skeletal age exam.
Exams containing more than one radiograph will not be included. Exams for which a trainee provides a preliminary interpretation will be excluded. No further exclusion criteria will be applied on the basis of image quality metrics or manufacturers. No exclusion criteria will be applied on the basis of patient chronological age.
Data sourced from ClinicalTrials.gov (NCT03530098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.