Pediatric Distal Radius US Study

NCT01937624 | Completed Results DMC

• 1 other identifier: Pro00021828
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the sensitivity and specificity of using a diagnostic musculoskeletal ultrasound in pediatric distal radius fractures in an outpatient setting. Ultrasound reliability and accuracy will be tested. The result of the diagnostic ultrasound will be compared to x-ray diagnosis under routine conditions in the investigator's injury and fracture treatment evening clinic. Data will be collected and recorded during the duration of the 12 week study. Through the literature review and experience with ultrasound, the investigators anticipate that diagnostic ultrasound will provide very high sensitivity and specificity in diagnosing distal radius fractures in children.

Conditions

Distal Radius Fractures

Keywords

Diagnostic ultrasound

Outcome Measures

Primary Outcomes (1)

• Presence of Fracture

  Diagnostic ultrasound will be used to determine if the bones do or do not have a fracture. Fractures will be based on the presence or absence of cortical disruption or irregularity on the ultrasound.

  Duration of office visit

Study Arms (1)

Diagnostic ultrasound and radiographic imaging

\- The diagnostic musculoskeletal ultrasound and x-rays will both be used to image bones in perpendicular and orthogonal planes over the distal radius visualizing the physis.

Device: Diagnostic Ultrasound; Radiation: X-ray imaging

Interventions

Diagnostic Ultrasound DEVICE

Also known as: Sonosite Ultrasound

Diagnostic ultrasound and radiographic imaging

X-ray imaging RADIATION

Diagnostic ultrasound and radiographic imaging

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients with wrist injury

You may qualify if:

• Pediatric patient with a wrist injury.

You may not qualify if:

• Gross deformity of the injured body part, suspected open fractures and the need for emergent surgery

Sponsors & Collaborators

• The Hawkins Foundation: lead

Study Sites (1)

Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Interventions

Ultrasonography; X-Rays

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Results Point of Contact

• Title: Dr. Kyle Cassas
• Organization: Steadman Hawkins Clinic of the Carolinas/Greenville Health System

kcassas@ghs.org

864-454-7422

Study Officials

• Kyle Cassas, MD

  Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 9, 2013
• Study Start: March 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 6, 2019
• Results First Posted: June 6, 2019

Record last verified: 2019-03

Locations

US (1)