Distal Radius Buckle Fracture Follow up Study

NCT03248687 | Completed

• 1 other identifier: 1000053044
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Proportion of children with splint use "almost all of the time" > 3 weeks duration

  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

  12 weeks

• Proportion of parents who rated the satisfaction with their care as "very satisfied/satisfied."

  4 weeks

• Health Economic Evaluation - dollar values will be obtained for patient and health care costs and compared between the groups.

  12 weeks

Study Arms (2)

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.

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.

Other: Follow up

Interventions

Follow up OTHER

The intervention will be method of follow up.

Home follow up; Primary Care Physician Follow up

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Physician Services Incorporated: collaborator

Study Sites (1)

Kathy Boutis

Toronto, Ontario, M5G1X8, Canada

Location

Related Publications (1)

• 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.

  PMID: 33500115 DERIVED

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will not know if the patient was followed at home or by a primary care provider.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician and Sr. Associate Scientist

Model Details: Enrolled patients will be randomized to one of two follow up arms

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 14, 2017
• Study Start: April 1, 2018
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: May 12, 2020

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)