The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information using the VolumeRAD advanced application.
The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information to support additional, on-label claims for GEHC's VolumeRAD advanced application. The results of this study are intended for use in the submission of FDA 510(k) claims in the United States.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
140
University of Pennsylvania Hospital - Department of Orthopaedic Surgery
Philadelphia, Pennsylvania, United States
RECRUITINGNumber of X-ray Images
collection of image sets from X-ray imaging exams for each complete and evaluable subject case
Time frame: 1 year
Number of DTS images
Collection of image sets from DTS imaging exams for each complete and evaluable subject case
Time frame: 1 year
Number of CT (or MRI) images
collection of image sets from CT (or MRI) imaging exams for each complete and evaluable subject case
Time frame: 1 year
Questionnaire about Diagnosis
collection of subject diagnosis (positive, negative, or inconclusive) for each complete and evaluable subject case
Time frame: 1 year
Questionnaire about Treatment
collection of treatment information (no treatment necessary, non-operative, operative) for each complete and evaluable subject case
Time frame: 1 year
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