Distal Radius Buckle Fracture Follow up Study
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|ClinicalTrials.gov Identifier: NCT03248687|
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : May 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Distal Radius Fracture||Other: Follow up||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||149 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Enrolled patients will be randomized to one of two follow up arms|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The outcomes assessor will not know if the patient was followed at home or by a primary care provider.|
|Primary Purpose:||Health Services Research|
|Official Title:||Home Management Versus Primary Care Physician Follow up in Children With Distal Radius Fractures: A Randomized Control Trial|
|Actual Study Start Date :||April 1, 2018|
|Actual Primary Completion Date :||November 30, 2019|
|Actual Study Completion Date :||November 30, 2019|
Experimental: Home follow up
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.
Other: Follow up
The intervention will be method of follow up.
Active Comparator: Primary Care Physician Follow up
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.
Other: Follow up
The intervention will be method of follow up.
- 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
- Proportion of children with splint use "almost all of the time" > 3 weeks duration [ Time Frame: 12 weeks ]The investigators will ask parents at three weeks if they use the splint, "almost never," "sometimes," "frequently," or "almost all of the time."
- 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 ]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
- Proportion of parents who rated the satisfaction with their care as "very satisfied/satisfied." [ Time Frame: 4 weeks ]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."
- Health Economic Evaluation - dollar values will be obtained for patient and health care costs and compared between the groups. [ Time Frame: 12 weeks ]The investigators will determine costs of patient and health care events using available sources for this information.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248687
|Toronto, Ontario, Canada, M5G1X8|