NCT03993691

Wrist Fracture Evaluation With a Desktop Orthopedic Tomosynthesis System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Fracture

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-05
• Primary completion: 2021-11-03
• Completion: 2021-11-03
• First posted: 2019-06-21
• Last updated: 2023-02-03
• Results posted: 2022-11-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study