Home Management of Pediatric Buckle Fractures

NCT06633094 | Active Not Recruiting DMC

• 1 other identifier: 21-1491
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine if a home management plan incorporating video education can effectively replace in-person visits for children aged 7-17 diagnosed with distal radius buckle fractures. The main questions it aims to answer are: Is a home management plan with video education non-inferior to in-person management for patient satisfaction? Is a home management plan superior to in-person management for reducing healthcare-related time, missed work/school, inappropriate care (e.g., rigid casting), and healthcare resource consumption? Researchers will compare the home management group to the in-person management group to see if video education can reduce healthcare costs and the burden on patients without compromising care quality. Participants will: Be randomized to either the in-person group or the video-based home management group. Complete a pediatric PROMIS assessment at baseline and 6 weeks. Complete a satisfaction survey at the conclusion of the study.

Conditions

Buckle Fracture; Patient Satisfaction

Keywords

Pediatric orthopedics; Distal radius fractures; Pediatric fractures; Fracture management; Patient education

Outcome Measures

Primary Outcomes (1)

• Patient-Reported Outcome Measurement Information System (PROMIS) Pediatric Short Form v2.0 - Physical Function Upper Extremity.

  This pediatric PROMIS assessment will be filled out at baseline and 6 weeks. All responses will be recorded within the study's REDCap database. Responses for each question:

  Baseline to 6 week follow-up

Secondary Outcomes (4)

• Parent Satisfaction Survey

  Baseline to 6 week follow-up

• Rigid Casting

  Baseline to 6 week follow-up

• Rate of follow-up X-rays

  Baseline to 6 week follow-up

• Provider time spent on delivering care

  Baseline to 6 week follow-up

Study Arms (2)

In-person management

NO INTERVENTION

In-person group will be followed with standard-of-care clinic visits scheduled with an pediatric orthopaedic Surgeon at Carilion Clinic Institute for Orthopaedics and Neurosciences. Participants will complete a pediatric PROMIS assessment at baseline and 6 weeks for . Patients/guardians will complete a satisfaction survey.

Home management

EXPERIMENTAL

Home-management group will be given access to an educational video explaining the nature of buckle fractures and treatment. all participants will enroll in MyChart to allow for asynchronous messages. Participants will complete a pediatric PROMIS assessment at baseline and 6 weeks. Patients/guardians will complete a satisfaction survey.

Other: Educational videos

Interventions

Educational videos OTHER

Internet will be used to deliver educational videos to subjects enrolled in the home management arm of the study which will be available on the Carilion Clinic Orthopaedic Education YouTube Channel. This will consist of a prerecorded video made by the three pediatric orthopaedic surgeons on this study explaining the nature of buckle fractures and treatment. Participants will be sent a link to the video over email (an example of a similar video in clinical use at Carilion Orthopaedics and the script of the video can be found in the study document attached).

Home management

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Any incoming pediatric orthopaedic referral containing the phrase: "distal radius fracture" "wrist fracture" or "buckle fracture
• Age 5-17
• Access to a smartphone, tablet, or computer
• Access to internet to download or view videos

You may not qualify if:

• Other fractures
• Discontinuity of both cortices of the distal radius.
• Metabolic bone disease
• Developmental delay affecting assessment
• Inability to utilize technology to view videos or follow instructions
• Lack of internet or telephone access
• Family/caregiver inability to speak or read English or Spanish

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Carilion Clinic Orthopaedic Surgery

Roanoke, Virginia, 24014, United States

Location

Related Publications (17)

• Landin LA. Epidemiology of children's fractures. J Pediatr Orthop B. 1997 Apr;6(2):79-83. doi: 10.1097/01202412-199704000-00002.

  PMID: 9165435 BACKGROUND

• Bae DS, Howard AW. Distal radius fractures: what is the evidence? J Pediatr Orthop. 2012 Sep;32 Suppl 2:S128-30. doi: 10.1097/BPO.0b013e31824b2545.

  PMID: 22890451 BACKGROUND

• Baig MN, Egan C. Improving Management of Paediatric Buckle Fracture in Orthopaedic Outpatients: A Completed Audit Loop. Cureus. 2017 Nov 8;9(11):e1829. doi: 10.7759/cureus.1829.

  PMID: 29326858 BACKGROUND

• Koelink E, Boutis K. Paediatrician office follow-up of common minor fractures. Paediatr Child Health. 2014 Oct;19(8):407-12. doi: 10.1093/pch/19.8.407.

  PMID: 25382996 BACKGROUND

• Symons S, Rowsell M, Bhowal B, Dias JJ. Hospital versus home management of children with buckle fractures of the distal radius. A prospective, randomised trial. J Bone Joint Surg Br. 2001 May;83(4):556-60. doi: 10.1302/0301-620x.83b4.11211.

  PMID: 11380131 BACKGROUND

• Firmin F, Crouch R. Splinting versus casting of "torus" fractures to the distal radius in the paediatric patient presenting at the emergency department (ED): a literature review. Int Emerg Nurs. 2009 Jul;17(3):173-8. doi: 10.1016/j.ienj.2009.03.006. Epub 2009 May 7.

  PMID: 19577205 BACKGROUND

• Boutis K. Common pediatric fractures treated with minimal intervention. Pediatr Emerg Care. 2010 Feb;26(2):152-7; quiz 158-62. doi: 10.1097/PEC.0b013e3181ce310c.

  PMID: 20145510 BACKGROUND

• Koelink E, Schuh S, Howard A, Stimec J, Barra L, Boutis K. Primary Care Physician Follow-up of Distal Radius Buckle Fractures. Pediatrics. 2016 Jan;137(1). doi: 10.1542/peds.2015-2262. Epub 2015 Dec 10.

  PMID: 26729537 BACKGROUND

• Plint AC, Perry JJ, Correll R, Gaboury I, Lawton L. A randomized, controlled trial of removable splinting versus casting for wrist buckle fractures in children. Pediatrics. 2006 Mar;117(3):691-7. doi: 10.1542/peds.2005-0801.

  PMID: 16510648 BACKGROUND

• Davidson JS, Brown DJ, Barnes SN, Bruce CE. Simple treatment for torus fractures of the distal radius. J Bone Joint Surg Br. 2001 Nov;83(8):1173-5. doi: 10.1302/0301-620x.83b8.11451.

  PMID: 11764434 BACKGROUND

• Williams BA, Palumbo NE, Phillips SA, Blakemore LC. What They Want - Caregiver and Patient Immobilization Preferences for Pediatric Buckle Fractures of the Wrist. Iowa Orthop J. 2020;40(1):83-90.

  PMID: 32742213 BACKGROUND

• Heikkinen K, Helena LK, Taina N, Anne K, Sanna S. A comparison of two educational interventions for the cognitive empowerment of ambulatory orthopaedic surgery patients. Patient Educ Couns. 2008 Nov;73(2):272-9. doi: 10.1016/j.pec.2008.06.015.

  PMID: 18678461 BACKGROUND

• Wright JE, Brown RR, Chadwick C, Karadaglis D. The use of the Internet by orthopaedic outpatients. J Bone Joint Surg Br. 2001 Nov;83(8):1096-7. doi: 10.1302/0301-620x.83b8.12390. No abstract available.

  PMID: 11764418 BACKGROUND

• Yi PH, Ganta A, Hussein KI, Frank RM, Jawa A. Readability of arthroscopy-related patient education materials from the American Academy of Orthopaedic Surgeons and Arthroscopy Association of North America Web sites. Arthroscopy. 2013 Jun;29(6):1108-12. doi: 10.1016/j.arthro.2013.03.003.

  PMID: 23726111 BACKGROUND

• Cotugna N, Vickery CE, Carpenter-Haefele KM. Evaluation of literacy level of patient education pages in health-related journals. J Community Health. 2005 Jun;30(3):213-9. doi: 10.1007/s10900-004-1959-x.

  PMID: 15847246 BACKGROUND

• Bini SA, Schilling PL, Patel SP, Kalore NV, Ast MP, Maratt JD, Schuett DJ, Lawrie CM, Chung CC, Steele GD. Digital Orthopaedics: A Glimpse Into the Future in the Midst of a Pandemic. J Arthroplasty. 2020 Jul;35(7S):S68-S73. doi: 10.1016/j.arth.2020.04.048. Epub 2020 Apr 22.

  PMID: 32416956 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction; Wrist Fractures

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Peter J Apel, MD, PhD

  Carilion Clinic Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Hand and Upper Extremity Surgeon

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 9, 2024
• Study Start: June 1, 2022
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)