Distal Radius Fracture Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | September 1, 2021 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania Hospital - Department of Orthopaedic Surgery | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
GE Healthcare |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of X-ray Images | collection of image sets from X-ray imaging exams for each complete and evaluable subject case | 1 year | |
Primary | Number of DTS images | Collection of image sets from DTS imaging exams for each complete and evaluable subject case | 1 year | |
Primary | 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 | Questionnaire about Diagnosis | collection of subject diagnosis (positive, negative, or inconclusive) for each complete and evaluable subject case | 1 year | |
Secondary | Questionnaire about Treatment | collection of treatment information (no treatment necessary, non-operative, operative) for each complete and evaluable subject case | 1 year |
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