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.

Study Overview

• Status: Unknown
• Conditions: Distal Radius Fracture; Scaphoid Fracture
• Intervention / Treatment: Device: DTS; Device: X-ray; Device: MRI or CT

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 Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Dooley; Phone Number: (215)-294-9650; Email: Mary.Dooley@uphs.upenn.edu
• Study Contact Backup: Name: David Steinberg, MD; Phone Number: (856)-220-6985; Email: David.Steinberg@uphs.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania Hospital - Department of Orthopaedic Surgery
      • Contact: David Steinberg, MD; Phone Number: 856-220-6985; Email: David.Steinberg@uphs.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Digital Tomosynthesis (DTS); Device: X-ray; Subjects undergo wrist imaging using standard X-ray imaging.; Other Names: 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 Names: Digital Tomosynthesis (DTS); Device: X-ray; Subjects undergo wrist imaging using standard X-ray imaging.; Other Names: X-ray imaging; Device: MRI or CT; Subjects may undergo wrist imaging using MRI or CT.; Other Names: Magnetic Resonance Imaging (MRI) or Computed Tomography (CT)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GE Healthcare

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 20, 2018
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: February 1, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (ACTUAL): February 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 30, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: 124.02-2018-GES-0001

Drug and device information, study documents

• 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