Clincosm LogoSign in Get a demo

Wrist Fracture Evaluation With a Desktop Orthopedic Tomosynthesis System

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Completed
CT.gov ID
NCT03993691
Collaborator
North Carolina Translational and Clinical Sciences Institute (Other)
30
Enrollment
1
Location
1
Arm
24
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Tomo-E scan
  • Device: Radiograph
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Wrist Fracture Evaluation With a Desktop Orthopedic Tomosynthesis System
Actual Study Start Date :
Nov 5, 2019
Actual Primary Completion Date :
Nov 3, 2021
Actual Study Completion Date :
Nov 3, 2021

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity [Upon completion of all study image data collection for all participants [approximately 1 year].]

      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 defined clinically by the attending orthopedic surgeon at 2 months post imaging.

    Secondary Outcome Measures

    1. Specificity [Upon completion of all study image data collection for all participants [approximately 1 year].]

      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 at 2 months post imaging.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599

    Sponsors and Collaborators

    • University of North Carolina, Chapel Hill
    • North Carolina Translational and Clinical Sciences Institute

    Investigators

    • Principal Investigator: Daniel Nissman, MD, MPH, UNC Chapel Hill

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of North Carolina, Chapel Hill
    ClinicalTrials.gov Identifier:
    NCT03993691
    Other Study ID Numbers:
    • 18-3132
    First Posted:
    Jun 21, 2019
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by University of North Carolina, Chapel Hill
    Scaphoid Fracture
    Wrist Fracture
    Distal Radius Fracture
    Additional relevant MeSH terms:
    Fractures, Bone

    Study Results

    No Results Posted as of Dec 8, 2021