Wrist Fracture Evaluation With a Desktop Orthopedic Tomosynthesis System

Trauma to the extremities such wrist, ankle, limb is very common and affects all population groups. It constitutes a significant public health issue. Standard radiography remains the basic imaging tool. However, as a 2-dimensional (2D) imaging modality it lacks sensitivity and specificity. Misdiagnosis rates are known to be high, especially for non-displaced fractures of the scaphoid and talus as well as erosions due to rheumatoid arthritis. Misdiagnosis leads to over treatment and unnecessary loss of productivity and quality of life including 6-12 weeks in a cast. Missed fractures can result in a chronic, non-healing fracture that may require surgical fixation and early arthritis of the joint. From a physician perspective, a missed diagnosis can result in a lawsuit and an expensive settlement/penalty.

Computed tomography (CT) offers high resolution and excellent visualization of bone and joint morphology, and Magnetic Resonance Imaging (MRI) delivers soft tissue and cartilage visibility. However, cost, space and workflow related issues make them prohibitive for small orthopedic clinics. Although the radiation dose of a CT scan has been reduced considerably in recent years, it is still significantly higher than a regular radiograph. The whole-body scanners also have difficulties in imaging patients in portable and weight-bearing conditions. Dedicated extremity CT scanners have been commercialized recently in an attempt to address the current deficiency. They still suffer from higher cost and at such have a limited installation base.

Study Overview

• Status: Completed
• Conditions: Fracture
• Intervention / Treatment: Device: Tomo-E scan; Device: Radiograph

Detailed Description

The aim of this one-year study is to demonstrate Tomo-E's clinical utility for diagnosis of wrist fractures. Tomo-E is a compact and stationary device that utilizes a distributed carbon nanotube (CNT) x-ray source array that will be specially designed for extremity imaging to collect all the projection views without any mechanical motion.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina At Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 or older
• Undergone radiographic imaging of wrist for presumed or known scaphoid, wrist or distal radius fractures within 2 weeks or are scheduled to undergo such imaging.
• Able to provide informed consent

Exclusion Criteria:

• Patients will an intervening surgical procedure performed prior to study imaging.
• Institutionalized subject (prisoner or nursing home patient)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All Participants; Participants that have undergone standard of care, conventional 2D radiographic imaging of wrist for presumed or known scaphoid, wrist or distal radius fractures will receive the Tomo-E scans within two weeks.	Device: Tomo-E scan; High-resolution limited-angle tomography positioning and examination will vary depending on injury.; Other Names: Digital Tomosynthesis; Device: Radiograph; Standard of Care radiographic imaging of wrist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	The sensitivity of Tomo-E is defined as the ability of readers (radiologists) to detect wrist fractures in patients. Diagnostic accuracy will be defined by the presence of a fracture as clinically determined by the attending orthopedic surgeon. All Tomo-E scans will be reviewed in a standardized reader study at the conclusion of all study imaging to determine the overall sensitivity of the device.	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity	The specificity of Tomo-E is defined as the ability to distinguish between individuals that do not have a wrist fracture. Diagnostic accuracy will be defined by the presence of a fracture as defined clinically by the attending orthopedic surgeon. All Tomo-E scans will be reviewed in a standardized reader study at the conclusion of all study imaging to determine the overall specificity of the device.	8 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: North Carolina Translational and Clinical Sciences Institute
• Investigators: Principal Investigator: Daniel Nissman, MD, MPH, UNC Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2019
• Primary Completion (Actual): November 3, 2021
• Study Completion (Actual): November 3, 2021

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Scaphoid Fracture; Wrist Fracture; Distal Radius Fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 18-3132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Identified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: 9 to 36 months following publication
• IPD Sharing Access Criteria: The investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: Study Protocol

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