Distal Radius FracturesNCT01937624
Pediatric Distal Radius US Study
An observational study of Distal Radius Fractures, run by The Hawkins Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Diagnostic Ultrasound and X-ray imaging
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Nov 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients with wrist injury
Who may be able to join
- Pediatric patient with a wrist injury.
Who cannot join
- Gross deformity of the injured body part, suspected open fractures and the need for emergent surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System
Greenville, South Carolina, 29615
About this study
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
- Being tested
- Diagnostic Ultrasound, X-ray imaging
- Keywords
- Diagnostic ultrasound
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic UltrasoundDevice
Also called Sonosite Ultrasound
X-ray imagingRadiation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Diagnostic Ultrasound; Radiation: X-ray imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of office visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hawkins Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyle Cassas, MD, Principal investigator, Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937624
- Sponsor's protocol ID
- Pro00021828
- Status last verified
- Mar 2019
- First submitted
- 28 Aug 2013
- Last updated
- 6 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Distal Radius US Study
- ClinicalTrials.gov ID
- NCT01937624
- Acronym / sponsor ID
- Pro00021828
- Conditions
- Distal Radius Fractures
- Keywords
- Diagnostic ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- The Hawkins FoundationUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 9 Sep 2013 (estimated)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic ultrasound and radiographic imaging | – | Device: Diagnostic Ultrasound, Radiation: X-ray 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. |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients with wrist injury
Key inclusion criteria (1 listed)
- Pediatric patient with a wrist injury.
Key exclusion criteria (1 listed)
- Gross deformity of the injured body part, suspected open fractures and the need for emergent surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic UltrasoundAlso: Sonosite Ultrasound | Device | Diagnostic ultrasound and radiographic imaging |
| X-ray imaging | Radiation | Diagnostic ultrasound and radiographic imaging |
Primary outcome
Presence of Fracture
Time frame: Duration of office visit
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Cassas, MD principal investigator
Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Radius Fractures, run by The Hawkins Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Fracture (time frame: Duration of office visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.