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

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

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.

Inclusion Criteria for Control-arm Subjects:

Subjects who meet all of the following inclusion criteria may be enrolled in this study:

1. Are adults aged 18 years or older;
2. Are able and willing to comply with study procedures; and
3. 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:

1. Are documented as pregnant based on PI's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy;
2. 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:

1. Are adults aged 18 years or older;
2. Have a confirmed or suspected distal radius or scaphoid wrist fracture;
3. Have completed an X-ray imaging exam per standard of care;
4. Have a standard of care (SOC) CT or MRI exam ordered;
5. Are able and willing to complete DTS imaging exam (if not already completed);
6. Are able and willing to comply with study procedures; and
7. 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:

1. Are documented as pregnant based on PI's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy;
2. 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;
3. Have had prior reconstructive surgery or fixation in the wrist.