Distal Radius Buckle Fracture Follow up Study

Distal Radius Fracture Clinical Trial

Official title:

Home Management Versus Primary Care Physician Follow up in Children With Distal Radius Fractures: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248687
• Other study ID #: 1000053044
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: April 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

1. Children at risk for pathologic fractures such as those with congenital or acquired bony disease (Appendix I).

2. Congenital anomalies of the extremities which may complicate clinical or radiographic assessment.

3. 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.

4. Patients cognitively and developmentally delayed such that they are unable to communicate pain or have limited performance in activities of daily living at baseline.

5. Past history of ipsilateral distal radius/ulna fracture within 3 months of enrollment.

6. Patients who do not have phone or electronic mail access. This will preclude follow up of these patients.

7. Patients in whom the English language is so limited that consent and/or follow up is not possible.

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Other:
• Follow up
The intervention will be method of follow up.

Locations

Country	Name	City	State
Canada	Kathy Boutis	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Physician Services Incorporated

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Three weeks post injury
Secondary	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."	12 weeks
Secondary	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	12 weeks
Secondary	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."	4 weeks
Secondary	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.	12 weeks