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

Primary Purpose

Distal Radius Fracture, Scaphoid Fracture

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

DTS

X-ray

MRI or CT

About this trial

This is an interventional diagnostic trial for Distal Radius Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for Control-arm Subjects:

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

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

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

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

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

Sites / Locations

University of Pennsylvania Hospital - Department of Orthopaedic SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control-arm group

Test-arm group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of X-ray Images

collection of image sets from X-ray imaging exams for each complete and evaluable subject case

Number of DTS images

Collection of image sets from DTS imaging exams for each complete and evaluable subject case

Number of CT (or MRI) images

collection of image sets from CT (or MRI) imaging exams for each complete and evaluable subject case

Secondary Outcome Measures

Questionnaire about Diagnosis

collection of subject diagnosis (positive, negative, or inconclusive) for each complete and evaluable subject case

Questionnaire about Treatment

collection of treatment information (no treatment necessary, non-operative, operative) for each complete and evaluable subject case

Full Information

NCT ID

NCT03856450

First Posted

February 1, 2019

Last Updated

September 28, 2020

Sponsor

GE Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT03856450

Brief Title

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

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 20, 2018 (Actual)

Primary Completion Date

September 1, 2021 (Anticipated)

Study Completion Date

September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GE Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Distal Radius Fracture, Scaphoid Fracture

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control-arm group

Arm Type

Active Comparator

Arm Description

Arm Title

Test-arm group

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

DTS

Other Intervention Name(s)

Digital Tomosynthesis (DTS)

Intervention Description

Subjects undergo wrist imaging using DTS.

Intervention Type

Device

Intervention Name(s)

X-ray

Other Intervention Name(s)

X-ray imaging

Intervention Description

Subjects undergo wrist imaging using standard X-ray imaging.

Intervention Type

Device

Intervention Name(s)

MRI or CT

Other Intervention Name(s)

Magnetic Resonance Imaging (MRI) or Computed Tomography (CT)

Intervention Description

Subjects may undergo wrist imaging using MRI or CT.

Primary Outcome Measure Information:

Title

Number of X-ray Images

Description

collection of image sets from X-ray imaging exams for each complete and evaluable subject case

Time Frame

1 year

Title

Number of DTS images

Description

Collection of image sets from DTS imaging exams for each complete and evaluable subject case

Time Frame

1 year

Title

Number of CT (or MRI) images

Description

collection of image sets from CT (or MRI) imaging exams for each complete and evaluable subject case

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Questionnaire about Diagnosis

Description

collection of subject diagnosis (positive, negative, or inconclusive) for each complete and evaluable subject case

Time Frame

1 year

Title

Questionnaire about Treatment

Description

collection of treatment information (no treatment necessary, non-operative, operative) for each complete and evaluable subject case

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria for Control-arm Subjects: Subjects who meet all of the following inclusion criteria may be enrolled in this study: Are adults aged 18 years or older; Are able and willing to comply with study procedures; and 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: Are documented as pregnant based on PI's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy; 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: Are adults aged 18 years or older; Have a confirmed or suspected distal radius or scaphoid wrist fracture; Have completed an X-ray imaging exam per standard of care; Have a standard of care (SOC) CT or MRI exam ordered; Are able and willing to complete DTS imaging exam (if not already completed); Are able and willing to comply with study procedures; and 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: Are documented as pregnant based on PI's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy; 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; Have had prior reconstructive surgery or fixation in the wrist.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mary Dooley

Phone

(215)-294-9650

Mary.Dooley@uphs.upenn.edu

First Name & Middle Initial & Last Name or Official Title & Degree

David Steinberg, MD

Phone

(856)-220-6985

David.Steinberg@uphs.upenn.edu

Facility Information:

Facility Name

University of Pennsylvania Hospital - Department of Orthopaedic Surgery

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Steinberg, MD

Phone

856-220-6985

David.Steinberg@uphs.upenn.edu

12. IPD Sharing Statement

Learn more about this trial

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

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