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Wrist Fracture Evaluation With a Desktop Orthopedic Tomosynthesis System

NCT03993691 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-02-03

Study results available
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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.

Conditions

  • Fracture

Interventions

DEVICE

Tomo-E scan

High-resolution limited-angle tomography positioning and examination will vary depending on injury.

DEVICE

Radiograph

Standard of Care radiographic imaging of wrist.

Sponsors & Collaborators

  • North Carolina Translational and Clinical Sciences Institute

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Daniel Nissman, MD, MPH · UNC Chapel Hill

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-05
Primary Completion
2021-11-03
Completion
2021-11-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03993691 on ClinicalTrials.gov