Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Distal Radius Buckle Fracture Follow up Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03248687
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : May 12, 2020
Sponsor:
Collaborator:
Physician Services Incorporated
Information provided by (Responsible Party):
Kathy Boutis, The Hospital for Sick Children

Tracking Information
First Submitted Date  ICMJE August 10, 2017
First Posted Date  ICMJE August 14, 2017
Last Update Posted Date May 12, 2020
Actual Study Start Date  ICMJE April 1, 2018
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
Activity Scales for Kids - Performance Version [ Time Frame: Three weeks post injury ]
A validated activity scale that measures the ability of a child's physical function
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
  • Proportion [ Time Frame: 12 weeks ]
    Proportion of children with splint use "almost all of the time" > 3 weeks duration
  • Proportion [ Time Frame: 12 weeks ]
    Proportion of children who received unscheduled visits to a physician for the index wrist injury, measured by parental report and Canadian Institute of Health Information data
  • Proportion [ Time Frame: 4 weeks ]
    Proportion of parents who rated the satisfaction with their care as "very satisfied/satisfied."
  • Health Economic Evaluation [ Time Frame: 12 weeks ]
    Cost comparisons in each group
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Distal Radius Buckle Fracture Follow up Study
Official Title  ICMJE Home Management Versus Primary Care Physician Follow up in Children With Distal Radius Fractures: A Randomized Control Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
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
Condition  ICMJE Distal Radius Fracture
Intervention  ICMJE Other: Follow up
The intervention will be method of follow up.
Study Arms  ICMJE
  • 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.
    Intervention: Other: 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.
    Intervention: Other: Follow up
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2020)
149
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2017)
125
Actual Study Completion Date  ICMJE November 30, 2019
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03248687
Other Study ID Numbers  ICMJE 1000053044
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kathy Boutis, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE Physician Services Incorporated
Investigators  ICMJE Not Provided
PRS Account The Hospital for Sick Children
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP