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Distal Radius Buckle Fracture Follow up Study

Primary Purpose

Distal Radius Fracture

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Follow up
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Distal Radius Fracture

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kathy Boutis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home follow up

Primary Care Physician Follow up

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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."
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
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."
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.

Full Information

First Posted
August 10, 2017
Last Updated
May 8, 2020
Sponsor
The Hospital for Sick Children
Collaborators
Physician Services Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT03248687
Brief Title
Distal Radius Buckle Fracture Follow up Study
Official Title
Home Management Versus Primary Care Physician Follow up in Children With Distal Radius Fractures: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Physician Services Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Enrolled patients will be randomized to one of two follow up arms
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will not know if the patient was followed at home or by a primary care provider.
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home follow up
Arm Type
Experimental
Arm Description
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.
Arm Title
Primary Care Physician Follow up
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Follow up
Intervention Description
The intervention will be method of follow up.
Primary Outcome Measure Information:
Title
Activity Scales for Kids - Performance Version, which is a validated activity scale that measures the ability of a child's physical function
Description
The Activity Scales for Kids is a validated activity scale that measures a child's physical function
Time Frame
Three weeks post injury
Secondary Outcome Measure Information:
Title
Proportion of children with splint use "almost all of the time" > 3 weeks duration
Description
The investigators will ask parents at three weeks if they use the splint, "almost never," "sometimes," "frequently," or "almost all of the time."
Time Frame
12 weeks
Title
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
Description
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
Time Frame
12 weeks
Title
Proportion of parents who rated the satisfaction with their care as "very satisfied/satisfied."
Description
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."
Time Frame
4 weeks
Title
Health Economic Evaluation - dollar values will be obtained for patient and health care costs and compared between the groups.
Description
The investigators will determine costs of patient and health care events using available sources for this information.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Facility Information:
Facility Name
Kathy Boutis
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33500115
Citation
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.
Results Reference
derived

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Distal Radius Buckle Fracture Follow up Study

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