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

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ClinicalTrials.gov Identifier: NCT03856450
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

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

Condition or disease Intervention/treatment Phase
Distal Radius Fracture Scaphoid Fracture Device: DTS Device: X-ray Device: MRI or CT Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control-arm group
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
Subjects undergo wrist imaging using DTS.
Other Name: Digital Tomosynthesis (DTS)

Device: X-ray
Subjects undergo wrist imaging using standard X-ray imaging.
Other Name: X-ray imaging
Experimental: Test-arm group
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
Subjects undergo wrist imaging using DTS.
Other Name: Digital Tomosynthesis (DTS)

Device: X-ray
Subjects undergo wrist imaging using standard X-ray imaging.
Other Name: X-ray imaging

Device: MRI or CT
Subjects may undergo wrist imaging using MRI or CT.
Other Name: Magnetic Resonance Imaging (MRI) or Computed Tomography (CT)


Outcome Measures
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Primary Outcome Measures :
  1. Number of X-ray Images [ Time Frame: 1 year ]
    collection of image sets from X-ray imaging exams for each complete and evaluable subject case

  2. Number of DTS images [ Time Frame: 1 year ]
    Collection of image sets from DTS imaging exams for each complete and evaluable subject case

  3. Number of CT (or MRI) images [ Time Frame: 1 year ]
    collection of image sets from CT (or MRI) imaging exams for each complete and evaluable subject case


Secondary Outcome Measures :
  1. Questionnaire about Diagnosis [ Time Frame: 1 year ]
    collection of subject diagnosis (positive, negative, or inconclusive) for each complete and evaluable subject case

  2. Questionnaire about Treatment [ Time Frame: 1 year ]
    collection of treatment information (no treatment necessary, non-operative, operative) for each complete and evaluable subject case


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03856450


Contacts
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Contact: Mary Dooley (215)-294-9650 Mary.Dooley@uphs.upenn.edu
Contact: David Steinberg, MD (856)-220-6985 David.Steinberg@uphs.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Hospital - Department of Orthopaedic Surgery Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: David Steinberg, MD    856-220-6985    David.Steinberg@uphs.upenn.edu   
Sponsors and Collaborators
GE Healthcare
  Study Documents (Full-Text)

Documents provided by GE Healthcare:
Study Protocol and Statistical Analysis Plan  [PDF] October 24, 2018

More Information
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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT03856450    
Other Study ID Numbers: 124.02-2018-GES-0001
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries