Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study

Study Overview
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Brief Summary
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The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information using the VolumeRAD advanced application.

Detailed Description
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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.

Official Title
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Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study

Conditions
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Distal Radius Fracture, Scaphoid Fracture

Intervention / Treatment
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* Device: DTS
* Device: X-ray
* Device: MRI or CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Control-arm Subjects: Subjects who meet all of the following inclusion criteria may be enrolled in this study: Are adults aged 18 years or older; Are able and willing to comply with study procedures; and Are able and willing to provide written informed consent to participate in this study. Exclusion Criteria for Control-arm Subjects: Subjects who meet any of the following exclusion criteria will be excluded from this study: Are documented as pregnant based on PI's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy; Have had known prior trauma in either wrist. Inclusion Criteria for Test-arm Subjects: Subjects who meet all of the following inclusion criteria may be enrolled in this study: Are adults aged 18 years or older; Have a confirmed or suspected distal radius or scaphoid wrist fracture; Have completed an X-ray imaging exam per standard of care; Have a standard of care (SOC) CT or MRI exam ordered; Are able and willing to complete DTS imaging exam (if not already completed); Are able and willing to comply with study procedures; and Are able and willing to provide written informed consent to participate in this study. Exclusion Criteria for Test-arm Subjects: Subjects who meet any of the following exclusion criteria will be excluded from this study: Are documented as pregnant based on PI's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy; Have additional trauma within the image field of view that either impacts the visualization or changes the treatment of the scaphoid or distal radius fracture; Have had prior reconstructive surgery or fixation in the wrist.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control-arm group<br>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. | Device: DTS<br>* Subjects undergo wrist imaging using DTS.<br>* Other names: Digital Tomosynthesis (DTS);Device: X-ray<br>* Subjects undergo wrist imaging using standard X-ray imaging.<br>* Other names: X-ray imaging;|
| Experimental: Test-arm group<br>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. | Device: DTS<br>* Subjects undergo wrist imaging using DTS.<br>* Other names: Digital Tomosynthesis (DTS);Device: X-ray<br>* Subjects undergo wrist imaging using standard X-ray imaging.<br>* Other names: X-ray imaging;Device: MRI or CT<br>* Subjects may undergo wrist imaging using MRI or CT.<br>* Other names: Magnetic Resonance Imaging (MRI) or Computed Tomography (CT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of X-ray Images | collection of image sets from X-ray imaging exams for each complete and evaluable subject case | 1 year | 
| Number of DTS images | Collection of image sets from DTS imaging exams for each complete and evaluable subject case | 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire about Diagnosis | collection of subject diagnosis (positive, negative, or inconclusive) for each complete and evaluable subject case | 1 year | 
| Questionnaire about Treatment | collection of treatment information (no treatment necessary, non-operative, operative) for each complete and evaluable subject case | 1 year |