NCT03856450

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

2.7 years

First QC Date

February 1, 2019

Last Update Submit

September 28, 2020

Conditions

Distal Radius FractureScaphoid Fracture

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Questionnaire about Diagnosis

    1 year

  • Questionnaire about Treatment

    1 year

Study Arms (2)

Control-arm group

ACTIVE COMPARATOR

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: DTSDevice: X-ray

Test-arm group

EXPERIMENTAL

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: DTSDevice: X-rayDevice: MRI or CT

Interventions

DTSDEVICE

Subjects undergo wrist imaging using DTS.

Also known as: Digital Tomosynthesis (DTS)
Control-arm groupTest-arm group
X-rayDEVICE

Subjects undergo wrist imaging using standard X-ray imaging.

Also known as: X-ray imaging
Control-arm groupTest-arm group
MRI or CTDEVICE

Subjects may undergo wrist imaging using MRI or CT.

Also known as: Magnetic Resonance Imaging (MRI) or Computed Tomography (CT)
Test-arm group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Hospital - Department of Orthopaedic Surgery

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Interventions

MammographyDiagnostic ImagingMagnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic Techniques and ProceduresDiagnosisTomography

Central Study Contacts

Mary Dooley

CONTACT

(215)-294-9650Mary.Dooley@uphs.upenn.edu

David Steinberg, MD

CONTACT

(856)-220-6985David.Steinberg@uphs.upenn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2019

First Posted

February 27, 2019

Study Start

December 20, 2018

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

September 30, 2020

Record last verified: 2020-09

Locations

US(1)