Clinical trial NCT03856450: Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study
Official title: Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Radius Fracture
Scaphoid Fracture
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2019-02-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of X-ray Images
timeFrame: 1 year
measure: Number of DTS images
timeFrame: 1 year
measure: Number of CT (or MRI) images
timeFrame: 1 year
Secondary outcomes:
measure: Questionnaire about Diagnosis
timeFrame: 1 year
measure: Questionnaire about Treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital - Department of Orthopaedic Surgery
state: Pennsylvania
Study officials:
References: