Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study
- Conditions
- Distal Radius FractureScaphoid Fracture
- Interventions
- Device: DTSDevice: X-rayDevice: MRI or CT
- Registration Number
- NCT03856450
- Lead Sponsor
- GE Healthcare
- Brief Summary
The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information using the VolumeRAD advanced application.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 140
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Control-arm group DTS The control-arm group will consist of healthy volunteers with no known prior trauma in the wrists. The diagnostic truth for subjects in the control-arm will be no fracture and the treatment truth will be no treatment. Test-arm group X-ray The test-arm group will consist of subjects who present with a wrist injury and initial SOC X-ray imaging results show a confirmed or suspected distal radius or scaphoid fracture, for which additional diagnostic imaging shall be ordered. Diagnostic truth for subjects in the test-arm will be the per-subject clinical diagnosis and the treatment truth will be the per-subject treatment received. Test-arm group DTS The test-arm group will consist of subjects who present with a wrist injury and initial SOC X-ray imaging results show a confirmed or suspected distal radius or scaphoid fracture, for which additional diagnostic imaging shall be ordered. Diagnostic truth for subjects in the test-arm will be the per-subject clinical diagnosis and the treatment truth will be the per-subject treatment received. Test-arm group MRI or CT The test-arm group will consist of subjects who present with a wrist injury and initial SOC X-ray imaging results show a confirmed or suspected distal radius or scaphoid fracture, for which additional diagnostic imaging shall be ordered. Diagnostic truth for subjects in the test-arm will be the per-subject clinical diagnosis and the treatment truth will be the per-subject treatment received. Control-arm group X-ray The control-arm group will consist of healthy volunteers with no known prior trauma in the wrists. The diagnostic truth for subjects in the control-arm will be no fracture and the treatment truth will be no treatment.
- Primary Outcome Measures
Name Time Method Number of CT (or MRI) images 1 year collection of image sets from CT (or MRI) imaging exams for each complete and evaluable subject case
Number of DTS images 1 year Collection of image sets from DTS imaging exams for each complete and evaluable subject case
Number of X-ray Images 1 year collection of image sets from X-ray imaging exams for each complete and evaluable subject case
- Secondary Outcome Measures
Name Time Method Questionnaire about Diagnosis 1 year collection of subject diagnosis (positive, negative, or inconclusive) for each complete and evaluable subject case
Questionnaire about Treatment 1 year collection of treatment information (no treatment necessary, non-operative, operative) for each complete and evaluable subject case
Trial Locations
- Locations (1)
University of Pennsylvania Hospital - Department of Orthopaedic Surgery
🇺🇸Philadelphia, Pennsylvania, United States