Wrist Fracture Evaluation With a Desktop Orthopedic Tomosynthesis System

NCT03993691 | Completed Results FDA Device

• 1 other identifier: 18-3132
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture

Keywords

Scaphoid Fracture; Wrist Fracture; Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Specificity

  8 months

Study Arms (1)

All Participants

EXPERIMENTAL

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; Device: Radiograph

Interventions

Tomo-E scan DEVICE

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

Also known as: Digital Tomosynthesis

All Participants

Radiograph DEVICE

Standard of Care radiographic imaging of wrist.

All Participants

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Fractures, Bone; Wrist Fractures

Interventions

Mammography; Diagnostic Imaging

Condition Hierarchy (Ancestors)

Wounds and Injuries; Wrist Injuries; Arm Injuries

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Director, Clinical Research Operations, Department of Radiology
• Organization: University of North Carolina at Chapel Hill

rad_research@med.unc.edu

919-966-4997

Study Officials

• Daniel Nissman, MD, MPH

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 21, 2019
• Study Start: November 5, 2019
• Primary Completion: November 3, 2021
• Study Completion: November 3, 2021
• Last Updated: February 3, 2023
• Results First Posted: November 7, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 to 36 months following publication
• 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.

Locations

US (1)