Distal Radius FractureNCT03248687
Distal Radius Buckle Fracture Follow up Study
A study testing Follow up in people with Distal Radius Fracture, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The investigators will be enrolling children with distal radius buckle fractures, treating them with a removable splint and randomizing them to follow up as needed vs required follow up with a primary care physician 1-2 weeks after the ED visit. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Follow up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2018to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Otherwise healthy children aged 5 to 17 years who present to the study ED within three days of a wrist injury that is diagnosed in the ED as a distal radius buckle fracture will be eligible for enrolment. Furthermore, approximately 15% of children with this fracture have an associated ulnar buckle or ulnar styloid fracture. In previous similar research, children with these associated ulnar fractures were included in the study population. Thus, distal radius buckle fractures with or without an associated buckle/styloid fracture of the distal ulna will be eligible for participation.
Who cannot join
- Children at risk for pathologic fractures such as those with congenital or acquired bony disease (Appendix I).
- Congenital anomalies of the extremities which may complicate clinical or radiographic assessment.
- Multisystem trauma and multiple fractures of the same limb since these patients would require additional management and follow-up beyond that of an isolated buckle fracture.
- Patients cognitively and developmentally delayed such that they are unable to communicate pain or have limited performance in activities of daily living at baseline.
- Past history of ipsilateral distal radius/ulna fracture within 3 months of enrollment.
- Patients who do not have phone or electronic mail access. This will preclude follow up of these patients.
- Patients in whom the English language is so limited that consent and/or follow up is not possible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home Management Versus Primary Care Physician Follow up in Children With Distal Radius Fractures: A Randomized Control Trial
The investigators will be enrolling children with distal radius buckle fractures, treating them with a removable splint and randomizing them to follow up as needed vs required follow up with a primary care physician 1-2 weeks after the ED visit.
Read the detailed description
Buckle fractures of the distal forearm that include the radius are the most common fracture in childhood, and the risk of this fracture occurring is about 1 in every 25 children.Despite the high frequency of this fracture, it is a very stable injury and thus can be safely treated with a removable wrist splint while the fracture heals. Furthermore, authors have concluded that since orthopedic intervention is exceedingly rare, this type of fracture may safely be followed by a primary care physician (PCP) or managed at home.
In Canada, about 50% of these injuries are routinely discharged from the ED for follow up with the PCP, instead of an orthopedic clinic. The investigators' work examined the management outcomes of 180 children with a distal radius buckle fractures who were treated in an ED with a removable splint, given anticipatory guidance, and advised to follow up in two weeks with their PCP. We demonstrated that PCP follow up was safe and effective, with about 90% of patients completing their care at the PCP without additional visits to an ED or orthopedic surgeon. All patients recovered as expected without complications. However, about 50% of these patients did not receive additional anticipatory guidance from their PCPs on duration of splint use or expected timing of return to usual activities at the PCP visit. Nevertheless, patients with and without this additional anticipatory guidance reported a similar duration of splint use and timing for return to usual activities, largely based on what was recommended at the ED visit. Since these injuries are inherently stable, carry an excellent prognosis, and are treated with a splint that can be removed at home in accordance with anticipatory guidance provided in the ED, it calls into question the need for any routine physician follow up of these common minor fractures.
If home management of distal radius buckle fracture after ED discharge demonstrated safety and effectiveness in a methodologically robust study, it would have clear advantages for patients and families, physicians, and the health care system. The frustrations of lengthy clinic visits and transport difficulties would be avoided. Parents would miss less time away from work or other priorities, and the patients themselves would not miss school. In medically under-serviced communities in particular, patients would avoid long travel distances to see a physician for this minor injury where physician intervention after the ED visit is rarely required. Furthermore, it will obviate the need to shift the care of these common minor fractures from the orthopedic surgeon to the PCP, relieving some pressure on health care practitioners and increase availability for other patients more in need of physician services. Importantly, the potential for reduced use of superfluous health care services for this common injury is also likely to result in health care cost savings.
- Conditions
- Distal Radius Fracture
- Being tested
- Follow up
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow upOther
The intervention will be method of follow up.
| Study group | Role | What they receive |
|---|---|---|
| Home follow up | Experimental | Patients with a distal radius buckle fracture treated in a removable splint will be provided with discharge instructions and anticipatory guidance without any scheduled physician follow up. Receives: Other: Follow up |
| Primary Care Physician Follow up | Active comparator | Patients with a distal radius buckle fracture treated in a removable splint will be provided with discharge instructions and anticipatory guidance with scheduled primary care physician follow up at 1-2 weeks post visit to the emergency department. Receives: Other: Follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity Scales for Kids - Performance Version, which is a validated activity scale that measures the ability of a child's physical function
The Activity Scales for Kids is a validated activity scale that measures a child's physical function
Measured: Three weeks post injury
Secondary outcomes (4)
Proportion of children with splint use "almost all of the time" > 3 weeks duration
The investigators will ask parents at three weeks if they use the splint, "almost never," "sometimes," "frequently," or "almost all of the time."
Measured: 12 weeks
Proportion of children who received unscheduled visits to a physician for the index wrist injury, obtained by parental report and Canadian Institute of Health Information data
At 12 weeks, the investigators will determine which children visited a physician for the index wrist injury as per parental report and/or data available from CIHI
Measured: 12 weeks
Proportion of parents who rated the satisfaction with their care as "very satisfied/satisfied."
The investigators will ask parents to rate the satisfaction with their care at 4 weeks on the following scale: "unsatisfied," somewhat satisfied," and "very satisfied."
Measured: 4 weeks
Health Economic Evaluation - dollar values will be obtained for patient and health care costs and compared between the groups.
The investigators will determine costs of patient and health care events using available sources for this information.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start1 Apr 2018
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled patients will be randomized to one of two follow up arms
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Physician Services Incorporated
- Responsible party
- Principal investigator, Kathy Boutis, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248687
- Sponsor's protocol ID
- 1000053044
- Status last verified
- Apr 2019
- First submitted
- 10 Aug 2017
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colaco K, Willan A, Stimec J, Barra L, Davis A, Howard A, Boutis K. Home Management Versus Primary Care Physician Follow-up of Patients With Distal Radius Buckle Fractures: A Randomized Controlled Trial. Ann Emerg Med. 2021 Feb;77(2):163-173. doi: 10.1016/j.annemergmed.2020.07.039. Epub 2020 Oct 21.
PubMed 33500115
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Management Versus Primary Care Physician Follow up in Children With Distal Radius Fractures: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03248687
- Acronym / sponsor ID
- 1000053044
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Physician Services Incorporated
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will be enrolling children with distal radius buckle fractures, treating them with a removable splint and randomizing them to follow up as needed vs required follow up with a primary care physician 1-2 weeks after the ED visit.
Detailed description
Buckle fractures of the distal forearm that include the radius are the most common fracture in childhood, and the risk of this fracture occurring is about 1 in every 25 children.Despite the high frequency of this fracture, it is a very stable injury and thus can be safely treated with a removable wrist splint while the fracture heals. Furthermore, authors have concluded that since orthopedic intervention is exceedingly rare, this type of fracture may safely be followed by a primary care physician (PCP) or managed at home.
In Canada, about 50% of these injuries are routinely discharged from the ED for follow up with the PCP, instead of an orthopedic clinic. The investigators' work examined the management outcomes of 180 children with a distal radius buckle fractures who were treated in an ED with a removable splint, given anticipatory guidance, and advised to follow up in two weeks with their PCP. We demonstrated that PCP follow up was safe and effective, with about 90% of patients completing their care at the PCP without additional visits to an ED or orthopedic surgeon. All patients recovered as expected without complications. However, about 50% of these patients did not receive additional anticipatory guidance from their PCPs on duration of splint use or expected timing of return to usual activities at the PCP visit. Nevertheless, patients with and without this additional anticipatory guidance reported a similar duration of splint use and timing for return to usual activities, largely based on what was recommended at the ED visit. Since these injuries are inherently stable, carry an excellent prognosis, and are treated with a splint that can be removed at home in accordance with anticipatory guidance provided in the ED, it calls into question the need for any routine physician follow up of these common minor fractures.
If home management of distal radius buckle fracture after ED discharge demonstrated safety and effectiveness in a methodologically robust study, it would have clear advantages for patients and families, physicians, and the health care system. The frustrations of lengthy clinic visits and transport difficulties would be avoided. Parents would miss less time away from work or other priorities, and the patients themselves would not miss school. In medically under-serviced communities in particular, patients would avoid long travel distances to see a physician for this minor injury where physician intervention after the ED visit is rarely required. Furthermore, it will obviate the need to shift the care of these common minor fractures from the orthopedic surgeon to the PCP, relieving some pressure on health care practitioners and increase availability for other patients more in need of physician services. Importantly, the potential for reduced use of superfluous health care services for this common injury is also likely to result in health care cost savings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Enrolled patients will be randomized to one of two follow up arms
| Arm | Type | Receives |
|---|---|---|
| Home follow up | Experimental | Other: Follow upPatients with a distal radius buckle fracture treated in a removable splint will be provided with discharge instructions and anticipatory guidance without any scheduled physician follow up. |
| Primary Care Physician Follow up | Active comparator | Other: Follow upPatients with a distal radius buckle fracture treated in a removable splint will be provided with discharge instructions and anticipatory guidance with scheduled primary care physician follow up at 1-2 weeks post visit to the emergency department. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Otherwise healthy children aged 5 to 17 years who present to the study ED within three days of a wrist injury that is diagnosed in the ED as a distal radius buckle fracture will be eligible for enrolment. Furthermore, approximately 15% of children with this fracture have an associated ulnar buckle or ulnar styloid fracture. In previous similar research, children with these associated ulnar fractures were included in the study population. Thus, distal radius buckle fractures with or without an associated buckle/styloid fracture of the distal ulna will be eligible for participation.
Key exclusion criteria (7 listed)
- Children at risk for pathologic fractures such as those with congenital or acquired bony disease (Appendix I).
- Congenital anomalies of the extremities which may complicate clinical or radiographic assessment.
- Multisystem trauma and multiple fractures of the same limb since these patients would require additional management and follow-up beyond that of an isolated buckle fracture.
- Patients cognitively and developmentally delayed such that they are unable to communicate pain or have limited performance in activities of daily living at baseline.
- Past history of ipsilateral distal radius/ulna fracture within 3 months of enrollment.
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 |
|---|---|---|
| Follow upThe intervention will be method of follow up. | Other | Home follow up, Primary Care Physician Follow up |
Primary outcome
Activity Scales for Kids - Performance Version, which is a validated activity scale that measures the ability of a child's physical function
Time frame: Three weeks post injury
The Activity Scales for Kids is a validated activity scale that measures a child's physical function
4 secondary outcomes
Proportion of children with splint use "almost all of the time" > 3 weeks duration
Time frame: 12 weeks
Proportion of children who received unscheduled visits to a physician for the index wrist injury, obtained by parental report and Canadian Institute of Health Information data
Time frame: 12 weeks
Proportion of parents who rated the satisfaction with their care as "very satisfied/satisfied."
Time frame: 4 weeks
Health Economic Evaluation - dollar values will be obtained for patient and health care costs and compared between the groups.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 33500115Colaco K, Willan A, Stimec J, Barra L, Davis A, Howard A, Boutis K. Home Management Versus Primary Care Physician Follow-up of Patients With Distal Radius Buckle Fractures: A Randomized Controlled Trial. Ann Emerg Med. 2021 Feb;77(2):163-173. doi: 10.1016/j.annemergmed.2020.07.039. Epub 2020 Oct 21.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow up in people with Distal Radius Fracture, run by The Hospital for Sick Children at 1 site in Canada.
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 7 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 12 May 2020. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Activity Scales for Kids - Performance Version, which is a validated activity scale that measures the ability of a child's physical function (time frame: Three weeks post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03248687, which also lists 1 linked publication.
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 12 May 2020.