Trial Outcomes & Findings for Pediatric Distal Radius US Study (NCT NCT01937624)

NCT ID: NCT01937624

Last Updated: 2019-06-06

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 51 participants
• Primary outcome timeframe: Duration of office visit
• Results posted on: 2019-06-06

Participant Flow

Participant milestones

Measure	Diagnostic Ultrasound and Radiographic Imaging The diagnostic musculoskeletal ultrasound and x-ray will both be used to image bones in perpendicular and orthogonal planes over the distal radius visualizing the physis. Diagnostic Ultrasound
Overall Study STARTED	51
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pediatric Distal Radius US Study

Baseline characteristics by cohort

Measure	Diagnostic Ultrasound and Radiographic Imaging n=51 Participants The diagnostic musculoskeletal ultrasound and x-ray will both be used to image bones in perpendicular and orthogonal planes over the distal radius visualizing the physis.
Age, Categorical <=18 years	51 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: Duration of office visit

Population: Each of the 51 participants received both an ultrasound and a x-ray.

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.

Outcome measures

Measure	Diagnostic Ultrasound and Radiographic Imaging n=51 Participants The diagnostic musculoskeletal ultrasound and x-ray will both be used to image bones in perpendicular and orthogonal planes over the distal radius visualizing the physis. Diagnostic Ultrasound
Presence of Fracture Ultrasound · Fracture YES	35 Participants
Presence of Fracture Ultrasound · Fracture No	16 Participants
Presence of Fracture X Ray · Fracture YES	34 Participants
Presence of Fracture X Ray · Fracture No	17 Participants

Adverse Events

Diagnostic Ultrasound and Radiographic Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kyle Cassas

Steadman Hawkins Clinic of the Carolinas/Greenville Health System

Phone: 864-454-7422

Email: kcassas@ghs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place